ObesityNCT01718886
European Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss
An observational study of Obesity and Weight Control, run by Obalon Therapeutics, Inc. at 2 sites in 2 countries.
Trial summary
The objective of this study is to evaluate the initial safety and preliminary effectiveness of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27 - 35 kg/m^2 Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Obesity, Weight Control
- What is being tested?
- Obalon Gastric Balloon
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2012to May 2012
- Phase
- Observational
- 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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients were selected from investigators' patient population and included patients with a BMI in the range of 27 - 35 kg/m^2
Who may be able to join
- Were between 21-64 years of age;
- Had a BMI 27-35 Kg/cm
- Did not have a history of weight reduction over 5% of body weight over the past 6 months
- Were able to comply with all study requirements for the duration of the study as outlined in the protocol. This included complying with the visit schedule as well as study specific procedures such as: electrocardiography, endoscopy, upper gastrointestinal radiography and clinical lab testing
- Were able to understand and willing to provide written informed consent
Who cannot join
- Experienced any difficulty in swallowing;
- Had unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
- Taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and not willingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
- Taking blood pressure medications, unless their blood pressure was controlled and they have been at stable dose for at least 3 months;
- Had type 1 diabetes or Type 2 diabetes requiring oral medications or insulin;
- Had a history or symptoms of thyroid disease which is not controlled by medication;
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- Had severe renal, hepatic, pulmonary disease or cancer;
- Had past history of gastrointestinal surgery (excluding uncomplicated appendectomy);
- Had any abnormal stenosis or obstruction of the GI tract;
- Had a history of adhesive peritonitis;
- Had a previously diagnosed hiatal hernia greater than 2cm;
- Had any abnormality of the esophagus, stomach or pylorus;
- Had history of severe esophagitis;
- Had history or symptoms of esophageal and/or gastric varices;
- Had history or congenital or acquired GI anomalies (e.g. atresias, stricture, and /or diverticula);
- Had history or symptoms of inflammatory bowel disease, such as Chron's disease;
- Had history of/ signs and /or symptoms of duodenal or gastric ulcer;
- Untreated H.Pylori
- Had history or signs of dysphasia, achalasia or symptoms of or GI motility;
- Were undergoing chronic steroid or immunosuppressive therapy;
- Were pregnant or breastfeeding or had the intention of becoming pregnant during the study;
- Had placement of previous intragastric balloon or similar device;
- Were using pharmaceutical agents for weight loss;
- Were drinking alcohol in excess or using illicit drugs;
- Had bulimia or binge eating disorders;
- Had impending gastric surgery 30 days post balloon removal;
- Had planned flying or scuba diving activities during balloon residence time;
- Had any other condition that, in the opinion of the investigator, would interfere with their participation and compliance with the study (i.e. psychosocial issues);
- Were participating in other investigational study protocols. If a subject had recently completed participation in another drug or device study, the subject must have completed that study at least 30 days prior to being enrolled in this study;
- Had history or known allergies to any component of the device materials, including but not limited to allergies to porcine proteins.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Belgium1 site
Department of Gastroenterology, Erasme Hospital
Brussels, 6B1070
France1 site
Service D'exploration Functionelle Digestive, Hospital Edouard Harriot
Lyon, Cedex, 69473
About this study
Official title: Feasibility Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss
The objective of this study is to evaluate the initial safety and preliminary effectiveness of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27 - 35 kg/m^2
- Conditions
- Obesity, Weight Control
- Being tested
- Obalon Gastric Balloon
- Keywords
- Obesity, Weight loss, Weight control, Intragastric balloon, gastric balloon
- Medical subject headings
- Obesity, Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Obalon Gastric BalloonDevice
| Study group | Role | What they receive |
|---|---|---|
| Obalon Gastric Balloon | Patients received 1-3 Obalon Gastric Balloons over a period of 12 weeks Receives: Device: Obalon Gastric Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Excess Weight Loss based on an ideal BMI of 25.
Measured: 12 weeks
Assessment of all adverse events.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2012 (estimated)
- Study startJan 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Obalon Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Fancois Mion, MD, Principal investigator, Hospital Edouard HarriotJacques Deviere, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01718886
- Sponsor's protocol ID
- PTL-1000-0018
- Status last verified
- Oct 2012
- First submitted
- 29 Oct 2012
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study to Evaluate Preliminary Safety and Efficacy of Multiple Obalon Gastric Balloons for 12 Weeks as an Aid for Weight Loss
- ClinicalTrials.gov ID
- NCT01718886
- Acronym / sponsor ID
- PTL-1000-0018
- Conditions
- Obesity, Weight Control
- Keywords
- Obesity, Weight loss, Weight control, Intragastric balloon, gastric balloon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Obalon Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 31 Oct 2012 (estimated)
- 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 objective of this study is to evaluate the initial safety and preliminary effectiveness of the Obalon intragastric balloon system in European subjects with a BMI in the range of 27 - 35 kg/m^2
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Obalon Gastric Balloon | – | Device: Obalon Gastric BalloonPatients received 1-3 Obalon Gastric Balloons over a period of 12 weeks |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients were selected from investigators' patient population and included patients with a BMI in the range of 27 - 35 kg/m^2
Key inclusion criteria (5 listed)
- Were between 21-64 years of age;
- Had a BMI 27-35 Kg/cm
- Did not have a history of weight reduction over 5% of body weight over the past 6 months
- Were able to comply with all study requirements for the duration of the study as outlined in the protocol. This included complying with the visit schedule as well as study specific procedures such as: electrocardiography, endoscopy, upper gastrointestinal radiography and clinical lab testing
- Were able to understand and willing to provide written informed consent
Key exclusion criteria (30 listed)
- Experienced any difficulty in swallowing;
- Had unstable angina, myocardial infarction within the past year, or heart disease classified within the New York Heart Association's Class III or IV functional capacity;
- Taking chronic aspirin or other non steroidal anti-inflammatory agents, or other medications known to be gastric irritants, and not willingness to discontinue the use of these concomitant medications, antiarrythmics, anti-anginal medications, anticoagulants or medications for congestive heart failure;
- Taking blood pressure medications, unless their blood pressure was controlled and they have been at stable dose for at least 3 months;
- Had type 1 diabetes or Type 2 diabetes requiring oral medications or insulin;
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 |
|---|---|---|
| Obalon Gastric Balloon | Device | Obalon Gastric Balloon |
Primary outcome
Percent Excess Weight Loss based on an ideal BMI of 25.
Time frame: 12 weeks
Assessment of all adverse events.
Time frame: 12 weeks
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 31 Oct 2012.
- Sponsor's websiteLink provided by the sponsor.
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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.
Fancois Mion, MD principal investigator
Hospital Edouard Harriot
Jacques Deviere principal investigator
Erasme University Hospital
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Weight Control, run by Obalon Therapeutics, Inc. at 2 sites in 2 countries.
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 5 inclusion and 30 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 31 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium, France. 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?
Percent Excess Weight Loss based on an ideal BMI of 25. (time frame: 12 weeks). 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 31 Oct 2012.