Endoscopic Sleeve Gastroplasty (ESG) for the Treatment of Obesity

NCT06339320 | Recruiting FDA Device

• 1 other identifier: PRO00037835
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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).

Conditions

Endoscopic Sleeve Gastroplasty; Obesity

Keywords

Obesity; Weight loss; Endoscopic Sleeve Gastroplasty (ESG)

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  30 days post-procedure

Secondary Outcomes (2)

• Change in body mass index (BMI) measured by kg/m2

  BMI (kg/m2) measured day of procedure, 4 weeks, 3 months, 6 months, and 12 month intervals

• Change in hemoglobin A1C (%)

  A1C measured pre-procedure, 3 months, 6 months, and 12 month intervals

Study Arms (1)

ESG Procedure

OTHER

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

Procedure: Endoscopic Sleeve Gastroplasty (ESG); Device: Apollo OverStitch endoscopic suturing device

Interventions

Endoscopic Sleeve Gastroplasty (ESG) 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.

ESG Procedure

Apollo OverStitch endoscopic suturing device 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.

ESG Procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (2)

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Houston Methodist Hospital - Sugarland

Sugar Land, Texas, 77479, United States

RECRUITING

Related Publications (6)

• 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.

  PMID: 35908555 BACKGROUND

• 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.

  PMID: 28017845 BACKGROUND

• 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.

  PMID: 30578757 BACKGROUND

• 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.

  PMID: 31932205 BACKGROUND

• 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.

  PMID: 29110192 BACKGROUND

• 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.

  PMID: 35248571 BACKGROUND

MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Thomas R McCarty, MD, MPH

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas R McCarty, MD, MPH

CONTACT

713-363-7436; tommccarty3@houstonmethodist.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Retrospective Registry Study

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 1, 2024
• Study Start: February 28, 2024
• Primary Completion (Estimated): October 1, 2033
• Study Completion (Estimated): October 1, 2033
• Last Updated: April 1, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)