Obesity & OverweightGastricOnNCT07869758
Gastric On in Obesity Management: Evaluation of the Safety and Efficacy of the 6-Month Gastric Balloon (Prospective)
A study testing GastricOn intragastric balloon in people with Obesity & Overweight, run by Rigicon, Inc. at 1 site in Turkey (Türkiye).
Trial summary
The goal of this clinical study is to learn whether the GastricOn 6-Month Gastric Balloon helps adults with obesity lose weight, and how safe it is. The GastricOn balloon is a soft, temporary device that is placed in the stomach through the mouth using an endoscope (a thin, flexible tube with a camera), without… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- GastricOn intragastric balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 18 Dec 2025to 2 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ≥18 and ≤60 years.
- BMI ≥30 kg/m² and ≤40 kg/m².
- History of obesity (BMI ≥30 kg/m²) for at least 2 years.
- Prior attempt at more conservative weight-loss alternatives, such as supervised diet, exercise and behavioral modification programs.
- Agreement to participate in a supervised diet and behavioral modification program designed to enhance long-term weight-loss maintenance.
- Willingness to comply with the requirements specified in the protocol, including adherence to the visit schedule.
- Ability to provide written informed consent.
Who cannot join
- Presence of more than one intragastric balloon at the same time.
- Prior gastrointestinal surgery.
- Any inflammatory disease of the gastrointestinal (GI) tract, including specific inflammation such as esophagitis, gastric ulcer, duodenal ulcer, cancer or Crohn's disease.
- Any potential gastrointestinal bleeding condition, such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia, or other congenital anomalies of the GI tract such as atresia or stenosis.
- A large hiatal hernia (greater than 5 cm), or a hiatal hernia of 5 cm or less associated with severe or intractable gastroesophageal reflux symptoms.
- Structural abnormalities of the esophagus or pharynx, such as stricture or diverticulum, that could impede passage of the delivery catheter and/or endoscope.
Show all 22Show fewer
- Any other severe motility disorder that could pose a safety risk during removal of the device.
- Presence of a gastric mass.
- Presence of severe coagulopathy.
- Presence of hepatic insufficiency or cirrhosis.
- Any other medical condition that would preclude elective endoscopy, such as poor general health or a history and/or symptoms of severe renal, hepatic, cardiac and/or pulmonary disease.
- Serious or uncontrolled psychiatric illness or disorder that could compromise the participant's understanding of follow-up visits or compliance with device removal after 6 months.
- Alcoholism or drug addiction.
- Individuals who are unwilling or unable to take prescribed proton pump inhibitor medication for the duration of device placement.
- Individuals who do not agree to participate in an institutionally supervised diet and behavioral modification program with regular medical follow-up.
- Individuals taking aspirin, anti-inflammatory agents, anticoagulants or other gastric irritants on a daily basis who are not taking these medications under medical supervision.
- Women who are pregnant, breastfeeding or planning to become pregnant within the next year; known or suspected allergy to materials contained in the GastricOn 6-Month Gastric Balloon.
- Prior (within 60 days of study day 1) or ongoing participation in a clinical trial, or current or prior use of an investigational drug or device (within 60 days of study day 1), or use of any intragastric balloon prior to this study.
- Obesity of genetic origin.
- Prior bariatric surgery, or considering bariatric surgery during the study.
- Concomitant use of weight-loss medications, weight-loss supplements or herbal weight-loss preparations, or unwillingness to refrain from their use.
- Presence of any condition or circumstance that, in the opinion of the investigator, could place the participant at significant risk or substantially interfere with the participant's participation in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
İstanbul Aydın Üniversitesi VM Medical Park Florya Hastanesi
Istanbul
About this study
The goal of this clinical study is to learn whether the GastricOn 6-Month Gastric Balloon helps adults with obesity lose weight, and how safe it is. The GastricOn balloon is a soft, temporary device that is placed in the stomach through the mouth using an endoscope (a thin, flexible tube with a camera), without surgery. Once in place, it is filled with saline (salt water). By taking up space in the stomach, it helps people feel full sooner and eat less. The balloon stays in the stomach for about 6 months and is then removed the same way.
The main questions this study aims to answer are:
Read more
How much of their total body weight do participants lose 26 weeks after the balloon is placed? How often do serious side effects related to the device or the procedure occur?
Researchers will also look at changes in body mass index (BMI), excess weight loss, appetite, eating habits and participant satisfaction.
About 70 adults aged 18 to 60 years with a BMI between 30 and 40 kg/m² will take part at 3 hospitals in Türkiye. All participants will receive the balloon; there is no comparison group.
Participants will:
Have screening tests, including a physical exam, blood tests and an endoscopy of the stomach Have the balloon placed under light sedation and stay for observation for 1 to 2 hours before going home Take a stomach acid-reducing medicine (proton pump inhibitor) while the balloon is in place Follow a supervised diet and lifestyle program Attend follow-up visits on Day 7 and at Weeks 4, 12, 24 and 26, where their weight is measured, side effects are checked and questionnaires are completed Have the balloon removed under light sedation at Week 24
Participants will have access to a 24/7 advice line during the study.
Read the detailed description
Background and Rationale
Obesity is a growing global public health problem associated with serious comorbidities, including type 2 diabetes, hypertension, cardiovascular disease and certain cancers, and it contributes substantially to morbidity and mortality. Conventional weight-loss strategies such as diet, exercise and behavioral modification often produce limited long-term success, particularly in individuals with moderate to severe obesity. For many patients, these conservative measures are insufficient, and more effective interventions are needed to achieve and maintain meaningful weight loss.
Intragastric balloons (IGBs) have emerged as a minimally invasive, temporary and reversible option for weight management in patients who do not respond adequately to lifestyle modification alone. IGBs occupy space within the stomach, promoting early satiety and reducing food intake. They have been shown to produce clinically meaningful short-term weight loss, may serve as a bridge to long-term weight-management strategies or bariatric surgery, and may improve obesity-related metabolic parameters. IGBs also provide an alternative for patients who are not candidates for, or do not wish to undergo, bariatric surgery.
Investigational Device
The GastricOn 6-Month Gastric Balloon (sponsor: Rigicon, Inc.) is a saline-filled intragastric balloon representing a new generation of IGB design. Compared with earlier-generation balloons, it features an optimized shape and expandable volume intended to improve positioning within the stomach, enhance patient comfort and reduce the incidence of adverse events. The balloon surface is treated with a specialized coating intended to minimize complications such as gastric ulceration and premature balloon deflation. The balloon is placed and removed endoscopically and is intended to remain in the stomach for approximately 6 months.
Although the device has shown promise in preliminary studies, safety and efficacy data in a larger population are needed. This study is designed to evaluate the GastricOn 6-Month Gastric Balloon in a real-world clinical setting.
Study Objectives
The primary objective is to evaluate the efficacy and safety of the GastricOn 6-Month Gastric Balloon in adults with obesity, measured by the percentage of total body weight loss (%TBWL) at 26 weeks and the incidence of device- and procedure-related serious adverse events (SAEs). The safety target is an SAE rate below 15%.
Secondary objectives are to evaluate changes in BMI; to calculate the percentage of excess weight loss (%EWL); to assess nutrition, appetite and patient satisfaction; to evaluate the effect of the balloon on longer-term weight loss; and to analyze the frequency of adverse events (AEs) and SAEs.
Hypotheses
The primary hypothesis is that the GastricOn 6-Month Gastric Balloon will produce a significant %TBWL at 26 weeks. Secondary hypotheses are that BMI and %EWL will decrease markedly; that appetite control and satiety will improve; that obesity-related metabolic parameters (e.g., blood glucose, cholesterol, blood pressure) will be favorably affected; that the rate of device- and procedure-related SAEs will be below 15%; and that patient satisfaction will be high.
Study Design
This is a prospective, multicenter, open-label, single-arm clinical investigation conducted at 3 hospitals in Türkiye. Approximately 70 adults aged 18 to 60 years with a BMI of 30 to 40 kg/m² and a history of obesity for at least 2 years will be enrolled. Participants will serve as their own controls. Because all participants receive the same intervention, no randomization or blinding will be used. The overall study duration is planned to be 12 months. Each participant's treatment period is approximately 6 months, followed by a post-removal follow-up visit at Week 26.
Participants will be recruited through announcements in hospitals and clinics, referrals from healthcare professionals, weight-loss volunteer pools, collaboration with dietitian and endocrinology clinics, and social media, online announcements and information sessions.
Study Procedures
Screening and enrollment: Eligibility will be assessed against the inclusion and exclusion criteria. Written informed consent will be obtained before any study procedure. Screening includes a medical history, physical examination, BMI measurement, laboratory tests and diagnostic endoscopy.
Balloon placement: The balloon will be placed endoscopically under mild sedation and filled with saline to a volume of 400 to 700 cc. It will then be released to float freely in the stomach. Participants will be observed for 1 to 2 hours after the procedure and then discharged. Participants will take a prescribed proton pump inhibitor for the duration of balloon placement and will take part in a supervised diet and behavioral modification program with regular medical follow-up.
Follow-up visits:
Day 7: assessment of adaptation to the balloon, side effects and adverse events Week 4: BMI measurement, weight loss, adverse events and dietary compliance Week 12: BMI change, nutritional status, appetite assessment and patient satisfaction questionnaire Week 24: endoscopic balloon removal under mild sedation, weight-loss assessment and evaluation of complications Week 26: final follow-up and assessment of late adverse events
Unscheduled visits will be performed as clinically indicated. Participants who miss scheduled visits will be followed up by telephone. A 24/7 advice line will be available throughout the study.
Safety Monitoring
Participant safety will be supported by strict eligibility criteria, a baseline medical and endoscopic evaluation, post-procedure observation after placement and removal, and systematic recording and evaluation of all AEs and SAEs at each visit. Participants who experience symptoms such as severe abdominal pain, gastrointestinal bleeding or signs of obstruction will receive immediate medical evaluation. An early balloon removal protocol will be applied if complications occur, and emergency surgical intervention may be required for serious complications such as bowel obstruction or gastric perforation.
Participants may be withdrawn from the study at their own request, if continued participation is judged unsafe because of an SAE or unexpected adverse effects, for non-compliance with protocol requirements, or if their health status changes significantly. Withdrawn participants will receive standard care appropriate to their condition, and reasons for withdrawal will be documented.
The study may be terminated early if the SAE rate exceeds 15%, if life-threatening complications increase markedly, if severe allergic reactions or intolerable side effects occur, if the study is unlikely to meet its scientific objectives, at the request of regulatory authorities or the Ethics Committee, or because of device-related technical, manufacturing or financial issues. In that case, all participants will be informed and their medical follow-up will be ensured.
Data Collection and Statistical Analysis
Data will be recorded on a Case Report Form (CRF) for each participant, including participants who withdraw. The primary endpoint (%TBWL at Week 26) will be analyzed using a paired t-test or analysis of covariance (ANCOVA), with a two-sided p-value below 0.05 considered statistically significant. Change in BMI will be analyzed using descriptive statistics and repeated-measures ANOVA. %EWL will be summarized as mean values and analyzed over time. AEs and SAEs will be reported using descriptive statistics. Appetite and patient satisfaction questionnaires will be evaluated using Likert scales. Missing data will be handled using the last observation carried forward (LOCF) method, supported by sensitivity analyses.
Ethics and Regulatory Compliance
The study will be conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice, the EU Medical Device Regulation (2017/745) and the clinical research regulations of the Ministry of Health of the Republic of Türkiye. Ethics Committee approval will be obtained before study initiation and before any protocol amendment. Participant confidentiality will be maintained, and study records will be retained for at least 15 years after study completion. Study conduct will be overseen through periodic on-site monitoring visits covering participant safety, data integrity, protocol compliance and the informed consent process.
- Conditions
- Obesity & Overweight
- Being tested
- GastricOn intragastric balloon
- Keywords
- intragastric balloon, gastric balloon, endoscopic bariatric therapy, weight loss, total body weight loss, minimally invasive, GastricOn
- Medical subject headings
- Obesity, Overweight, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GastricOn intragastric balloonDevice
Also called IGB
The GastricOn 6-Month Gastric Balloon is a saline-filled intragastric balloon placed endoscopically under mild sedation. After insertion, it is filled with 400-700 cc of sterile saline and released to float freely in the stomach, where it occupies space to promote early satiety and reduce food intake. Compared with earlier-generation balloons, it has an optimized shape and expandable volume intended to improve positioning and comfort, and a specially coated surface intended to reduce gastric ulceration and premature deflation. The balloon remains in place for 24 weeks and is then removed endoscopically under mild sedation. During treatment, participants take a prescribed proton pump inhibitor and follow a supervised diet and behavioral modification program.
| Study group | Role | What they receive |
|---|---|---|
| the efficacy and safety of the GastricOn | Experimental | the efficacy and safety of the GastricOn 6-Month Gastric Balloon with respect to weight loss Receives: Device: GastricOn intragastric balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Total Body Weight Loss (%TBWL)
Percentage of total body weight lost from baseline, calculated as [(baseline weight - Week 26 weight) / baseline weight] × 100. Body weight will be measured at each study visit using calibrated scales.
Measured: Baseline to Week 26
Incidence of Device- and Procedure-Related Serious Adverse Events (SAEs)
Percentage of participants who experience at least one serious adverse event related to the GastricOn 6-Month Gastric Balloon or to the placement or removal procedure. The study's safety target is an SAE rate below 15%.
Measured: From balloon placement to Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2026
- Study start18 Dec 2025
- Primary completion2 Oct 2026
- Study completion2 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective, multicenter, open-label, single-arm clinical investigation
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rigicon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07869758
- Sponsor's protocol ID
- GB_6M_2025
- Acronym
- GastricOn
- Status last verified
- Oct 2025
- First submitted
- 6 Oct 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared outside the study team. In accordance with the study protocol, study records may be reviewed only by authorized regulatory authorities, the Ethics Committee and the sponsor, and participant confidentiality will be maintained in line with ICH-GCP and applicable Turkish data protection requirements. Aggregate results will be made available through publication and results reporting.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric On in Obesity Management: Evaluation of the Safety and Efficacy of the 6-Month Gastric Balloon (Prospective)
- ClinicalTrials.gov ID
- NCT07869758
- Acronym / sponsor ID
- GastricOn / GB_6M_2025
- Conditions
- Obesity & Overweight
- Keywords
- intragastric balloon, gastric balloon, endoscopic bariatric therapy, weight loss, total body weight loss, minimally invasive, GastricOn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Rigicon, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 2 Oct 2026 (actual)
- Study completion
- 2 Oct 2026 (actual)
- First posted
- 13 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical study is to learn whether the GastricOn 6-Month Gastric Balloon helps adults with obesity lose weight, and how safe it is. The GastricOn balloon is a soft, temporary device that is placed in the stomach through the mouth using an endoscope (a thin, flexible tube with a camera), without surgery. Once in place, it is filled with saline (salt water). By taking up space in the stomach, it helps people feel full sooner and eat less. The balloon stays in the stomach for about 6 months and is then removed the same way.
The main questions this study aims to answer are:
How much of their total body weight do participants lose 26 weeks after the balloon is placed? How often do serious side effects related to the device or the procedure occur?
Researchers will also look at changes in body mass index (BMI), excess weight loss, appetite, eating habits and participant satisfaction.
About 70 adults aged 18 to 60 years with a BMI between 30 and 40 kg/m² will take part at 3 hospitals in Türkiye. All participants will receive the balloon; there is no comparison group.
Participants will:
Have screening tests, including a physical exam, blood tests and an endoscopy of the stomach Have the balloon placed under light sedation and stay for observation for 1 to 2 hours before going home Take a stomach acid-reducing medicine (proton pump inhibitor) while the balloon is in place Follow a supervised diet and lifestyle program Attend follow-up visits on Day 7 and at Weeks 4, 12, 24 and 26, where their weight is measured, side effects are checked and questionnaires are completed Have the balloon removed under light sedation at Week 24
Participants will have access to a 24/7 advice line during the study.
Detailed description
Background and Rationale
Obesity is a growing global public health problem associated with serious comorbidities, including type 2 diabetes, hypertension, cardiovascular disease and certain cancers, and it contributes substantially to morbidity and mortality. Conventional weight-loss strategies such as diet, exercise and behavioral modification often produce limited long-term success, particularly in individuals with moderate to severe obesity. For many patients, these conservative measures are insufficient, and more effective interventions are needed to achieve and maintain meaningful weight loss.
Intragastric balloons (IGBs) have emerged as a minimally invasive, temporary and reversible option for weight management in patients who do not respond adequately to lifestyle modification alone. IGBs occupy space within the stomach, promoting early satiety and reducing food intake. They have been shown to produce clinically meaningful short-term weight loss, may serve as a bridge to long-term weight-management strategies or bariatric surgery, and may improve obesity-related metabolic parameters. IGBs also provide an alternative for patients who are not candidates for, or do not wish to undergo, bariatric surgery.
Investigational Device
The GastricOn 6-Month Gastric Balloon (sponsor: Rigicon, Inc.) is a saline-filled intragastric balloon representing a new generation of IGB design. Compared with earlier-generation balloons, it features an optimized shape and expandable volume intended to improve positioning within the stomach, enhance patient comfort and reduce the incidence of adverse events. The balloon surface is treated with a specialized coating intended to minimize complications such as gastric ulceration and premature balloon deflation. The balloon is placed and removed endoscopically and is intended to remain in the stomach for approximately 6 months.
Although the device has shown promise in preliminary studies, safety and efficacy data in a larger population are needed. This study is designed to evaluate the GastricOn 6-Month Gastric Balloon in a real-world clinical setting.
Study Objectives
The primary objective is to evaluate the efficacy and safety of the GastricOn 6-Month Gastric Balloon in adults with obesity, measured by the percentage of total body weight loss (%TBWL) at 26 weeks and the incidence of device- and procedure-related serious adverse events (SAEs). The safety target is an SAE rate below 15%.
Secondary objectives are to evaluate changes in BMI; to calculate the percentage of excess weight loss (%EWL); to assess nutrition, appetite and patient satisfaction; to evaluate the effect of the balloon on longer-term weight loss; and to analyze the frequency of adverse events (AEs) and SAEs.
Hypotheses
The primary hypothesis is that the GastricOn 6-Month Gastric Balloon will produce a significant %TBWL at 26 weeks. Secondary hypotheses are that BMI and %EWL will decrease markedly; that appetite control and satiety will improve; that obesity-related metabolic parameters (e.g., blood glucose, cholesterol, blood pressure) will be favorably affected; that the rate of device- and procedure-related SAEs will be below 15%; and that patient satisfaction will be high.
Study Design
This is a prospective, multicenter, open-label, single-arm clinical investigation conducted at 3 hospitals in Türkiye. Approximately 70 adults aged 18 to 60 years with a BMI of 30 to 40 kg/m² and a history of obesity for at least 2 years will be enrolled. Participants will serve as their own controls. Because all participants receive the same intervention, no randomization or blinding will be used. The overall study duration is planned to be 12 months. Each participant's treatment period is approximately 6 months, followed by a post-removal follow-up visit at Week 26.
Participants will be recruited through announcements in hospitals and clinics, referrals from healthcare professionals, weight-loss volunteer pools, collaboration with dietitian and endocrinology clinics, and social media, online announcements and information sessions.
Study Procedures
Screening and enrollment: Eligibility will be assessed against the inclusion and exclusion criteria. Written informed consent will be obtained before any study procedure. Screening includes a medical history, physical examination, BMI measurement, laboratory tests and diagnostic endoscopy.
Balloon placement: The balloon will be placed endoscopically under mild sedation and filled with saline to a volume of 400 to 700 cc. It will then be released to float freely in the stomach. Participants will be observed for 1 to 2 hours after the procedure and then discharged. Participants will take a prescribed proton pump inhibitor for the duration of balloon placement and will take part in a supervised diet and behavioral modification program with regular medical follow-up.
Follow-up visits:
Day 7: assessment of adaptation to the balloon, side effects and adverse events Week 4: BMI measurement, weight loss, adverse events and dietary compliance Week 12: BMI change, nutritional status, appetite assessment and patient satisfaction questionnaire Week 24: endoscopic balloon removal under mild sedation, weight-loss assessment and evaluation of complications Week 26: final follow-up and assessment of late adverse events
Unscheduled visits will be performed as clinically indicated. Participants who miss scheduled visits will be followed up by telephone. A 24/7 advice line will be available throughout the study.
Safety Monitoring
Participant safety will be supported by strict eligibility criteria, a baseline medical and endoscopic evaluation, post-procedure observation after placement and removal, and systematic recording and evaluation of all AEs and SAEs at each visit. Participants who experience symptoms such as severe abdominal pain, gastrointestinal bleeding or signs of obstruction will receive immediate medical evaluation. An early balloon removal protocol will be applied if complications occur, and emergency surgical intervention may be required for serious complications such as bowel obstruction or gastric perforation.
Participants may be withdrawn from the study at their own request, if continued participation is judged unsafe because of an SAE or unexpected adverse effects, for non-compliance with protocol requirements, or if their health status changes significantly. Withdrawn participants will receive standard care appropriate to their condition, and reasons for withdrawal will be documented.
The study may be terminated early if the SAE rate exceeds 15%, if life-threatening complications increase markedly, if severe allergic reactions or intolerable side effects occur, if the study is unlikely to meet its scientific objectives, at the request of regulatory authorities or the Ethics Committee, or because of device-related technical, manufacturing or financial issues. In that case, all participants will be informed and their medical follow-up will be ensured.
Data Collection and Statistical Analysis
Data will be recorded on a Case Report Form (CRF) for each participant, including participants who withdraw. The primary endpoint (%TBWL at Week 26) will be analyzed using a paired t-test or analysis of covariance (ANCOVA), with a two-sided p-value below 0.05 considered statistically significant. Change in BMI will be analyzed using descriptive statistics and repeated-measures ANOVA. %EWL will be summarized as mean values and analyzed over time. AEs and SAEs will be reported using descriptive statistics. Appetite and patient satisfaction questionnaires will be evaluated using Likert scales. Missing data will be handled using the last observation carried forward (LOCF) method, supported by sensitivity analyses.
Ethics and Regulatory Compliance
The study will be conducted in accordance with the Declaration of Helsinki, ICH Good Clinical Practice, the EU Medical Device Regulation (2017/745) and the clinical research regulations of the Ministry of Health of the Republic of Türkiye. Ethics Committee approval will be obtained before study initiation and before any protocol amendment. Participant confidentiality will be maintained, and study records will be retained for at least 15 years after study completion. Study conduct will be overseen through periodic on-site monitoring visits covering participant safety, data integrity, protocol compliance and the informed consent process.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective, multicenter, open-label, single-arm clinical investigation
| Arm | Type | Receives |
|---|---|---|
| the efficacy and safety of the GastricOn | Experimental | Device: GastricOn intragastric balloonthe efficacy and safety of the GastricOn 6-Month Gastric Balloon with respect to weight loss |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age ≥18 and ≤60 years.
- BMI ≥30 kg/m² and ≤40 kg/m².
- History of obesity (BMI ≥30 kg/m²) for at least 2 years.
- Prior attempt at more conservative weight-loss alternatives, such as supervised diet, exercise and behavioral modification programs.
- Agreement to participate in a supervised diet and behavioral modification program designed to enhance long-term weight-loss maintenance.
Key exclusion criteria (22 listed)
- Presence of more than one intragastric balloon at the same time.
- Prior gastrointestinal surgery.
- Any inflammatory disease of the gastrointestinal (GI) tract, including specific inflammation such as esophagitis, gastric ulcer, duodenal ulcer, cancer or Crohn's disease.
- Any potential gastrointestinal bleeding condition, such as esophageal or gastric varices, congenital or acquired intestinal telangiectasia, or other congenital anomalies of the GI tract such as atresia or stenosis.
- A large hiatal hernia (greater than 5 cm), or a hiatal hernia of 5 cm or less associated with severe or intractable gastroesophageal reflux symptoms.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GastricOn intragastric balloonAlso: IGBThe GastricOn 6-Month Gastric Balloon is a saline-filled intragastric balloon placed endoscopically under mild sedation. After insertion, it is filled with 400-700 cc of sterile saline and released to float freely in the stomach, where it occupies space to promote early satiety and reduce food intake. Compared with earlier-generation balloons, it has an optimized shape and expandable volume intended to improve positioning and comfort, and a specially coated surface intended to reduce gastric ulceration and premature deflation. The balloon remains in place for 24 weeks and is then removed endoscopically under mild sedation. During treatment, participants take a prescribed proton pump inhibitor and follow a supervised diet and behavioral modification program. | Device | the efficacy and safety of the GastricOn |
Primary outcome
Percentage of Total Body Weight Loss (%TBWL)
Time frame: Baseline to Week 26
Percentage of total body weight lost from baseline, calculated as [(baseline weight - Week 26 weight) / baseline weight] × 100. Body weight will be measured at each study visit using calibrated scales.
Incidence of Device- and Procedure-Related Serious Adverse Events (SAEs)
Time frame: From balloon placement to Week 26
Percentage of participants who experience at least one serious adverse event related to the GastricOn 6-Month Gastric Balloon or to the placement or removal procedure. The study's safety target is an SAE rate below 15%.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared outside the study team. In accordance with the study protocol, study records may be reviewed only by authorized regulatory authorities, the Ethics Committee and the sponsor, and participant confidentiality will be maintained in line with ICH-GCP and applicable Turkish data protection requirements. Aggregate results will be made available through publication and results reporting.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GastricOn intragastric balloon in people with Obesity & Overweight, run by Rigicon, Inc. at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Total Body Weight Loss (%TBWL) (time frame: Baseline to Week 26). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.