Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

NCT ID: NCT06339320

Last Updated: 2024-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-28
• Study Completion Date: 2033-10-31

Brief 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. 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.

Conditions

Endoscopic Sleeve Gastroplasty; Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESG Procedure

Endoscopic Sleeve Gastroplasty for patients with obesity using the Apollo OverStitch endoscopic suturing device.

Group Type: OTHER

Endoscopic Sleeve Gastroplasty (ESG)

Intervention Type: PROCEDURE

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 device

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: PROCEDURE

Apollo OverStitch endoscopic suturing device

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Thomas R McCarty, MD, MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas R McCarty, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

The Methodist Hospital Research Institute

Locations

Houston Methodist Hospital

Houston, Texas, United States

Site Status: RECRUITING

Houston Methodist Hospital - Sugarland

Sugar Land, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Thomas R McCarty, MD, MPH

Role: CONTACT

tommccarty3@houstonmethodist.org

713-363-7436

Facility Contacts

Thomas R McCarty, MD, MPH

Role: primary

tommccarty3@houstonmethodist.org

713-363-7436

Thomas R McCarty, MD, MPH

Role: primary

tommccarty3@houstonmethodist.org

713-363-7436

References

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.

Reference Type: BACKGROUND

PMID: 35908555 (View on PubMed)

Sharaiha 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.

Reference Type: BACKGROUND

PMID: 28017845 (View on PubMed)

Alqahtani 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.

Reference Type: BACKGROUND

PMID: 30578757 (View on PubMed)

Singh 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.

Reference Type: BACKGROUND

PMID: 31932205 (View on PubMed)

Novikov 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.

Reference Type: BACKGROUND

PMID: 29110192 (View on PubMed)

Alqahtani 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.

Reference Type: BACKGROUND

PMID: 35248571 (View on PubMed)

Other Identifiers

PRO00037835

Identifier Type: -

Identifier Source: org_study_id