Endoscopic Sleeve GastroplastyNCT06339320
Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
A study testing Endoscopic Sleeve Gastroplasty (ESG) and Apollo OverStitch endoscopic suturing device in people with Endoscopic Sleeve Gastroplasty and Obesity, run by The Methodist Hospital Research Institute at 2 sites in United States.
Trial summary
The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endoscopic Sleeve Gastroplasty, Obesity
- What is being tested?
- Endoscopic Sleeve Gastroplasty (ESG) and Apollo OverStitch endoscopic suturing device
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Feb 2024to Oct 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with BMI 30 to 50 kg/m2
- Patients that have been unable able to lose weight, or maintain weight loss, through more conservative measures (i.e., lifestyle interventions including diet and exercise) per the FDA approval for the Apollo ESG device. Lifestyle interventions may include traditional diet and anaerobic or aerobic exercise, including resistance training.
Who cannot join
- Patients who are actively pregnant
- Active tobacco use (defined as tobacco within 4 weeks prior to the procedure)
- Active gastric mucosal lesions
- Active bleeding or potential bleeding gastric lesions (i.e., ulcers, erosive gastritis, varices, or vascular malformations)
- Neoplastic lesions (i.e., esophageal, gastric, or small bowel cancer)
- Hiatal hernia >5 cm
Show all 9Show fewer
- Severe coagulopathy and antiplatelet/anticoagulant therapy that cannot be corrected
- Psychiatric disorders not assessed or cleared by a psychologist or psychiatrist actively participating in that patient's care (i.e., affective disorders not under medical supervision or refractory to medical therapy and all eating disorders such as anorexia nervosa, binge eating disorder, specified feeding and eating disorders, avoidant restrictive food intake, and rumination)
- Patients with endoscopic interventions that are contraindicated
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Houston Methodist Hospital
Houston, Texas, 77030
Thomas R McCarty, MD, MPH, 713-363-7436, tommccarty3@houstonmethodist.org
- Recruiting
Houston Methodist Hospital - Sugarland
Sugar Land, Texas, 77479
Thomas R McCarty, MD, MPH, 713-363-7436, tommccarty3@houstonmethodist.org
About this study
The purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS).
Read the detailed description
Obesity has become an epidemic on a national and international scale with immense burden of disease. Approximately one out of every three United States (U.S.) adults are characterized as having obesity with the global prevalence having nearly tripled over the last four decades to include over 650 million people. Although diet and exercise are essential, these interventions alone typically result in only 1-3% total weight loss. Pharmacotherapy is effective but has side effects and carries the risk of weight recurrence once discontinued. While bariatric surgery is the most robust treatment option, only 1% of eligible patients undergo surgery, leaving a tremendous need for effective and safe therapies.
Helping to bridge this gap in available treatments, the endoscopic sleeve gastroplasty (ESG) procedure provides a way to improve access to validated, efficacious, and safe anti-obesity treatments. ESG is an endoscopic weight loss procedure. The procedure uses an endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with obesity (BMI 30-50 kg/m2) who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise. This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70% to 80% its original size. Following the procedure, the new stomach appears similar to the surgical sleeve stomach, although the procedure is considered less invasive with fewer complications compared to a surgical sleeve procedure.
This study aims to perform ESG for patients with obesity, defined as a BMI 30-50 kg/m2. Additionally, data collection of relevant weight-related and metabolic outcomes, including comorbidity resolution will be collected retrospectively from the study to assess efficacy and safety of the ESG procedure. Data collection for the MBSAQIP registry will be recorded on a monthly basis.
- Conditions
- Endoscopic Sleeve Gastroplasty, Obesity
- Being tested
- Endoscopic Sleeve Gastroplasty (ESG), Apollo OverStitch endoscopic suturing device
- Keywords
- Obesity, Weight loss, Endoscopic Sleeve Gastroplasty (ESG)
- 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.
Endoscopic Sleeve Gastroplasty (ESG)Procedure or surgery
The ESG procedure uses the Apollo OverStitch endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise. This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70% to 80% its original size. Using the Apollo OverStitch or APOLLO ESG and ESG SX Systems, the ESG procedure is performed be folding the stomach in on itself (endoscopically) and placing full-thickness sutures through the wall of the stomach to maintain this narrow, smaller size. Following the procedure, the new stomach appears similar to the surgical sleeve stomach, although the procedure is considered less invasive with fewer complications compared to a surgical sleeve gastrectomy.
Apollo OverStitch endoscopic suturing deviceDevice
Apollo ESG is the first and only device to be authorized by the FDA to perform the ESG procedure to facilitate weight loss in patients with obesity (BMI 30 to 50 kg/m2). The FDA identifies this generic type of device as an Endoscopic suturing device for altering gastric anatomy for weight loss.
| Study group | Role | What they receive |
|---|---|---|
| ESG Procedure | Other | Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device. Receives: Procedure: Endoscopic Sleeve Gastroplasty (ESG); Device: Apollo OverStitch endoscopic suturing device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with technically successful completion of the ESG procedure
Per the ASMBS, IRB approval must be for performing the ESG procedure, and not solely for data collection of outcomes from these procedures, with data collected by the MBSAQIP registry. Therefore, the primary outcome is performing the ESG procedure (defined as ability to successful complete the procedure). Procedural success will be defined by ability to successful reduce the size of the stomach using the Apollo OverStitch or APOLLO ESG and ESG SX systems. Technical success further identified by ability to insert the endoscopic suturing device, perform endoscopic reduction of the stomach, and success removal of the device.
Measured: Procedural completion over 10 year period
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Treatment-related adverse events as assessed by CTCAE v4.0 will be reviewed on a monthly basis by the bariatric medical director, bariatric clinical review, and program manager. Per the U.S. FDA, identified risks to health including device- and/or procedure-related adverse events include: death, gastrointestinal bleeding, obstruction, perforation, injury to organs adjacent to the stomach, perigastric leak, and nausea, infection, pain, pneumoperitoneum, pneumothorax, and pulmonary embolism, weight gain, and adverse tissue reaction. All patients are recorded and entered into this MBSAQIP registry with outcomes tracked in real-time via the electronic medical record, and all ESG complications discussed at the Metabolic and Bariatric Surgery Committee Meetings which are held quarterly. This includes monitoring emergency department visits, readmissions, and patient transfers to any inpatient facility during the 30-day postoperative period.
Measured: 30 days post-procedure
Secondary outcomes (2)
Change in body mass index (BMI) measured by kg/m2
Data collection of relevant weight-related outcomes, including body mass index (BMI, measured in kg/m2) will be performed on day of procedure and at relevant follow-up periods (day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals). From this, change in BMI with be measured to determine change at relevant follow-up intervals.
Measured: BMI (kg/m2) measured day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals
Change in hemoglobin A1C (%)
Data collection of relevant comorbidity-related outcomes, including A1C (measured in percentage) will be performed pre-procedure and at relevant follow-up periods (pre-procedure, 3 months, 6 months, and 12 month intervals). This will be measured for all patients, regardless of presence or absence of diabetes mellitus (DM). From this, change in A1C will be calculated to determine and change in blood glucose (A1C).
Measured: A1C measured pre-procedure, 3 months, 6 months, and 12 month intervals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start28 Feb 2024
- Primary completionOct 2033 (estimated)
- Study completionOct 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Endoscopic Sleeve GastroplastyStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe sponsor's other registered studies.
- 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
- Retrospective Registry Study
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas R McCarty, MD, MPH, The Methodist Hospital Research Institute
- Investigators
- Thomas R McCarty, MD, MPH, Principal investigator, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339320
- Sponsor's protocol ID
- PRO00037835
- Status last verified
- Mar 2024
- First submitted
- 11 Mar 2024
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.
PubMed 35908555Sharaiha RZ, Kumta NA, Saumoy M, Desai AP, Sarkisian AM, Benevenuto A, Tyberg A, Kumar R, Igel L, Verna EC, Schwartz R, Frissora C, Shukla A, Aronne LJ, Kahaleh M. Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. Clin Gastroenterol Hepatol. 2017 Apr;15(4):504-510. doi: 10.1016/j.cgh.2016.12.012. Epub 2016 Dec 23.
PubMed 28017845Alqahtani A, Al-Darwish A, Mahmoud AE, Alqahtani YA, Elahmedi M. Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients. Gastrointest Endosc. 2019 Jun;89(6):1132-1138. doi: 10.1016/j.gie.2018.12.012. Epub 2018 Dec 19.
PubMed 30578757Singh S, Hourneaux de Moura DT, Khan A, Bilal M, Ryan MB, Thompson CC. Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Surg Obes Relat Dis. 2020 Feb;16(2):340-351. doi: 10.1016/j.soard.2019.11.012. Epub 2019 Dec 10.
PubMed 31932205Novikov AA, Afaneh C, Saumoy M, Parra V, Shukla A, Dakin GF, Pomp A, Dawod E, Shah S, Aronne LJ, Sharaiha RZ. Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? J Gastrointest Surg. 2018 Feb;22(2):267-273. doi: 10.1007/s11605-017-3615-7. Epub 2017 Nov 6.
PubMed 29110192Alqahtani AR, Elahmedi M, Aldarwish A, Abdurabu HY, Alqahtani S. Endoscopic gastroplasty versus laparoscopic sleeve gastrectomy: a noninferiority propensity score-matched comparative study. Gastrointest Endosc. 2022 Jul;96(1):44-50. doi: 10.1016/j.gie.2022.02.050. Epub 2022 Mar 3.
PubMed 35248571
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity
- ClinicalTrials.gov ID
- NCT06339320
- Acronym / sponsor ID
- PRO00037835
- Conditions
- Endoscopic Sleeve Gastroplasty, Obesity
- Keywords
- Obesity, Weight loss, Endoscopic Sleeve Gastroplasty (ESG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- Oct 2033 (estimated)
- Study completion
- Oct 2033 (estimated)
- First posted
- 1 Apr 2024 (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 purpose of this study is to evaluate endoscopic sleeve gastroplasty (ESG) for the treatment of obesity. The ESG procedure is an U.S. Food and Drug Administration (FDA) approved procedure for the treatment of obesity - patients with a body mass index (BMI) 30-50 kg/m2. This procedure is FDA approved; however, Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP)-Accredited centers (such as Houston Methodist Hospital) must receive approval from an Institutional Review Board (IRB) in order to perform primary procedures, such as ESG, that are not endorsed by the American Society for Metabolic and Bariatric Surgery (ASMBS).
Detailed description
Obesity has become an epidemic on a national and international scale with immense burden of disease. Approximately one out of every three United States (U.S.) adults are characterized as having obesity with the global prevalence having nearly tripled over the last four decades to include over 650 million people. Although diet and exercise are essential, these interventions alone typically result in only 1-3% total weight loss. Pharmacotherapy is effective but has side effects and carries the risk of weight recurrence once discontinued. While bariatric surgery is the most robust treatment option, only 1% of eligible patients undergo surgery, leaving a tremendous need for effective and safe therapies.
Helping to bridge this gap in available treatments, the endoscopic sleeve gastroplasty (ESG) procedure provides a way to improve access to validated, efficacious, and safe anti-obesity treatments. ESG is an endoscopic weight loss procedure. The procedure uses an endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with obesity (BMI 30-50 kg/m2) who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise. This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70% to 80% its original size. Following the procedure, the new stomach appears similar to the surgical sleeve stomach, although the procedure is considered less invasive with fewer complications compared to a surgical sleeve procedure.
This study aims to perform ESG for patients with obesity, defined as a BMI 30-50 kg/m2. Additionally, data collection of relevant weight-related and metabolic outcomes, including comorbidity resolution will be collected retrospectively from the study to assess efficacy and safety of the ESG procedure. Data collection for the MBSAQIP registry will be recorded on a monthly basis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective Registry Study
| Arm | Type | Receives |
|---|---|---|
| ESG Procedure | Other | Procedure: Endoscopic Sleeve Gastroplasty (ESG), Device: Apollo OverStitch endoscopic suturing deviceEndoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with BMI 30 to 50 kg/m2
- Patients that have been unable able to lose weight, or maintain weight loss, through more conservative measures (i.e., lifestyle interventions including diet and exercise) per the FDA approval for the Apollo ESG device. Lifestyle interventions may include traditional diet and anaerobic or aerobic exercise, including resistance training.
Key exclusion criteria (9 listed)
- Patients who are actively pregnant
- Active tobacco use (defined as tobacco within 4 weeks prior to the procedure)
- Active gastric mucosal lesions
- Active bleeding or potential bleeding gastric lesions (i.e., ulcers, erosive gastritis, varices, or vascular malformations)
- Neoplastic lesions (i.e., esophageal, gastric, or small bowel cancer)
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 |
|---|---|---|
| Endoscopic Sleeve Gastroplasty (ESG)The ESG procedure uses the Apollo OverStitch endoscopic suturing device, which has received FDA authorization as a minimally invasive procedure to facilitate weight loss for adults with who have been unable to lose weight or maintain weight loss through more conservative measures such as diet and exercise. This procedure involves endoscopic suturing to reduce the volume of the stomach endoscopically by approximately 70% to 80% its original size. Using the Apollo OverStitch or APOLLO ESG and ESG SX Systems, the ESG procedure is performed be folding the stomach in on itself (endoscopically) and placing full-thickness sutures through the wall of the stomach to maintain this narrow, smaller size. Following the procedure, the new stomach appears similar to the surgical sleeve stomach, although the procedure is considered less invasive with fewer complications compared to a surgical sleeve gastrectomy. | Procedure or surgery | ESG Procedure |
| Apollo OverStitch endoscopic suturing deviceApollo ESG is the first and only device to be authorized by the FDA to perform the ESG procedure to facilitate weight loss in patients with obesity (BMI 30 to 50 kg/m2). The FDA identifies this generic type of device as an Endoscopic suturing device for altering gastric anatomy for weight loss. | Device | ESG Procedure |
Primary outcome
Number of participants with technically successful completion of the ESG procedure
Time frame: Procedural completion over 10 year period
Per the ASMBS, IRB approval must be for performing the ESG procedure, and not solely for data collection of outcomes from these procedures, with data collected by the MBSAQIP registry. Therefore, the primary outcome is performing the ESG procedure (defined as ability to successful complete the procedure). Procedural success will be defined by ability to successful reduce the size of the stomach using the Apollo OverStitch or APOLLO ESG and ESG SX systems. Technical success further identified by ability to insert the endoscopic suturing device, perform endoscopic reduction of the stomach, and success removal of the device.
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Time frame: 30 days post-procedure
Treatment-related adverse events as assessed by CTCAE v4.0 will be reviewed on a monthly basis by the bariatric medical director, bariatric clinical review, and program manager. Per the U.S. FDA, identified risks to health including device- and/or procedure-related adverse events include: death, gastrointestinal bleeding, obstruction, perforation, injury to organs adjacent to the stomach, perigastric leak, and nausea, infection, pain, pneumoperitoneum, pneumothorax, and pulmonary embolism, weight gain, and adverse tissue reaction. All patients are recorded and entered into this MBSAQIP registry with outcomes tracked in real-time via the electronic medical record, and all ESG complications discussed at the Metabolic and Bariatric Surgery Committee Meetings which are held quarterly. This includes monitoring emergency department visits, readmissions, and patient transfers to any inpatient facility during the 30-day postoperative period.
2 secondary outcomes
Change in body mass index (BMI) measured by kg/m2
Time frame: BMI (kg/m2) measured day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals
Change in hemoglobin A1C (%)
Time frame: A1C measured pre-procedure, 3 months, 6 months, and 12 month intervals
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2024.
- Background: PubMed 35908555Abu Dayyeh BK, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC, Teixeira AF, Chapman CG, Kumbhari V, Ujiki MB, Ahrens J, Day C; MERIT Study Group; Galvao Neto M, Zundel N, Wilson EB. Endoscopic sleeve gastroplasty for treatment of class 1 and 2 obesity (MERIT): a prospective, multicentre, randomised trial. Lancet. 2022 Aug 6;400(10350):441-451. doi: 10.1016/S0140-6736(22)01280-6. Epub 2022 Jul 28.
- Background: PubMed 28017845Sharaiha RZ, Kumta NA, Saumoy M, Desai AP, Sarkisian AM, Benevenuto A, Tyberg A, Kumar R, Igel L, Verna EC, Schwartz R, Frissora C, Shukla A, Aronne LJ, Kahaleh M. Endoscopic Sleeve Gastroplasty Significantly Reduces Body Mass Index and Metabolic Complications in Obese Patients. Clin Gastroenterol Hepatol. 2017 Apr;15(4):504-510. doi: 10.1016/j.cgh.2016.12.012. Epub 2016 Dec 23.
- Background: PubMed 30578757Alqahtani A, Al-Darwish A, Mahmoud AE, Alqahtani YA, Elahmedi M. Short-term outcomes of endoscopic sleeve gastroplasty in 1000 consecutive patients. Gastrointest Endosc. 2019 Jun;89(6):1132-1138. doi: 10.1016/j.gie.2018.12.012. Epub 2018 Dec 19.
- Background: PubMed 31932205Singh S, Hourneaux de Moura DT, Khan A, Bilal M, Ryan MB, Thompson CC. Safety and efficacy of endoscopic sleeve gastroplasty worldwide for treatment of obesity: a systematic review and meta-analysis. Surg Obes Relat Dis. 2020 Feb;16(2):340-351. doi: 10.1016/j.soard.2019.11.012. Epub 2019 Dec 10.
- Background: PubMed 29110192Novikov AA, Afaneh C, Saumoy M, Parra V, Shukla A, Dakin GF, Pomp A, Dawod E, Shah S, Aronne LJ, Sharaiha RZ. Endoscopic Sleeve Gastroplasty, Laparoscopic Sleeve Gastrectomy, and Laparoscopic Band for Weight Loss: How Do They Compare? J Gastrointest Surg. 2018 Feb;22(2):267-273. doi: 10.1007/s11605-017-3615-7. Epub 2017 Nov 6.
- Background: PubMed 35248571Alqahtani AR, Elahmedi M, Aldarwish A, Abdurabu HY, Alqahtani S. Endoscopic gastroplasty versus laparoscopic sleeve gastrectomy: a noninferiority propensity score-matched comparative study. Gastrointest Endosc. 2022 Jul;96(1):44-50. doi: 10.1016/j.gie.2022.02.050. Epub 2022 Mar 3.
- Individual participant dataSharing planned: No
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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.
Thomas R McCarty, MD, MPH principal investigator
The Methodist Hospital Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Endoscopic Sleeve Gastroplasty (ESG) and Apollo OverStitch endoscopic suturing device in people with Endoscopic Sleeve Gastroplasty and Obesity, run by The Methodist Hospital Research Institute at 2 sites in United States.
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 2 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 1 Apr 2024. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas R McCarty, MD, MPH (713-363-7436, tommccarty3@houstonmethodist.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with technically successful completion of the ESG procedure (time frame: Procedural completion over 10 year period). 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?
On the ClinicalTrials.gov record for NCT06339320, which also lists 6 linked publications.
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 1 Apr 2024.