Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)
Multi-center ESG Randomized Interventional Trial (MERIT-Trial)
1 other identifier
interventional
208
1 country
9
Brief Summary
Endoscopic Sleeve Gastroplasty (ESG) is an endoscopic minimally invasive weight loss procedure where a commercially available, FDA approved, full-thickness endoscopic suturing device (Overstitch; Apollo Endosurgery, Austin, TX) is used to reduce the stomach volume by 80% through the creation of a restrictive endoscopic sleeve. This is accomplished by a series of endoscopically placed full-thickness sutures through the gastric wall, extending from the antrum to the gastroesophageal junction. Up to 200 participants at 9 locations in the United States will participate in this study. The ESG procedure has been performed clinically since 2013 in the United States. The investigators are completing this study to compare how effective the ESG is for achieving long-term weight loss when compared to lifestyle modification only, as well as to evaluate the long-term safety and durability of the procedure and its impact on quality of life. Results of this research may help support having this procedure covered by health insurance plans for future patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable obesity
Started Dec 2017
Longer than P75 for not_applicable obesity
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 20, 2017
CompletedFirst Submitted
Initial submission to the registry
January 16, 2018
CompletedFirst Posted
Study publicly available on registry
January 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 29, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2021
CompletedResults Posted
Study results publicly available
October 18, 2022
CompletedOctober 18, 2022
September 1, 2022
2.9 years
January 16, 2018
August 24, 2022
September 24, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Excess Weight Loss (EWL)
Percentage of excess weight loss in participants at 12 months from randomization. Calculated as (weight loss/baseline excess weight) x 100, where weight loss is defined as follow-up weight minus the initial weight, and baseline excess weight is defined as index weight minus ideal weight X (X=25 kg/m²)
12 months
Secondary Outcomes (16)
Number of Participants With ≥25% EWL
12 months
Number of Participants Off Or With Reduction in Antihypertensive Medications
12 months
Change in Blood Pressure
Baseline, 12 months
Change in Blood Pressure for ESG Intervention From Baseline to 24 Months
Baseline, 24 months
Number of Participants Off or With Reduction in Diabetes Medications
12 months
- +11 more secondary outcomes
Study Arms (3)
Control Group: Lifestyle Modification
ACTIVE COMPARATORParticipants randomized to the control group (lifestyle modification only) in Year 1 will undergo a standard moderate intensity life-style intervention during the first 12 months of participation.
Treatment Group: Overstitch ESG Procedure
EXPERIMENTALParticipants randomized to the treatment group will proceed to have the Overstitch Endoscopic Sleeve Gastroplasty (ESG) at the start of Year 1 and will undergo a standard moderate intensity life-style intervention during the first 12 months of participation. All patients undergoing ESG will go on a 6 weeks transitional diet.ESG patients will undergo a standard moderate intensity life-style intervention administered over 15 12 visits in the first year after ESG. ESG patients who have not achieved \>25% EWL at the end of Year 1 will undergo a repeat upper endoscopy at 52 to 60 weeks to assess the durability of the plications. Patients will continue follow-up with a modified lifestyle intervention program administered over 6 visits in the second year
Crossover Group: Lifestyle Intervention to ESG Procedure
EXPERIMENTALControl group participants (lifestyle modification only) who were compliant with at least 75% of visits in Year 1, have not achieved ≥25% EWL or have a BMI \>30 measured at the week 52 visit, and have no new psychosocial contraindications as deemed by the treatment team to the procedure will cross over to receive the Overstitch ESG in Year 2, in addition to the standard moderate intensity lifestyle intervention program of 12 months.
Interventions
Endoscopic Sleeve Gastroplasty (ESG), an endoscopic minimally-invasive weight loss procedure, utilizing a suturing device to reduce the stomach volume by 80% through the creation of sleeve. This is accomplished by a series of endoscopically placed stitches through the stomach wall.
Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
Eligibility Criteria
You may qualify if:
- Age 21-65
- BMI ≥ 30 and ≤40 kg/m²
- Willingness to comply with the substantial lifelong dietary restrictions required by the procedure
- History of failure with non-surgical weight-loss methods
- Willingness to follow protocol requirements, including signed informed consent, routine follow-up schedule, completing laboratory tests, and completing diet counseling
- Residing within a reasonable distance from the investigator's office and able to travel to the investigator to complete all routine follow- up visits
- Ability to give informed consent
- Women of childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
- \*\*\*There will be a quota for at least a) 50 patients with hypertension on one or more anti-hypertensive medication, b) 50 patients with type II diabetes mellitus on oral agents only with HgA1c ≤ 9, and thus the cohort of 200 patients will be stratified into three groups (Obesity, Obesity HTH, Obesity DM) and block randomized. No more than 50 participants without comorbidities will be enrolled in the trial.
You may not qualify if:
- History of foregut or gastrointestinal (GI) surgery (except uncomplicated cholecystectomy or appendectomy)
- Prior gastrointestinal surgery with sequelae, i.e. obstruction, and/or adhesive peritonitis or known abdominal adhesions.
- Prior open or laparoscopic bariatric surgery.
- Prior surgery of any kind on the esophagus, stomach or any type of hiatal hernia surgery.
- Any inflammatory disease of the gastrointestinal tract including esophagitis, Barrett's esophagus, gastric ulceration, duodenal ulceration, cancer or specific inflammation such as Crohn's disease.
- Potential upper gastrointestinal bleeding conditions such as esophageal or gastric varices, congenital or acquired intestinal telangiectasis, or other congenital anomalies of the gastrointestinal tract such as atresias or stenoses.
- A gastric mass or gastric polyps \> 1 cm in size.
- A hiatal hernia \> 4cm of axial displacement of the z-line above the diaphragm or severe or intractable gastro-esophageal reflux symptoms.
- A structural abnormality in the esophagus or pharynx such as a stricture or diverticulum that could impede passage of the endoscope.
- Achalasia or any other severe esophageal motility disorder
- Severe coagulopathy.
- Insulin-dependent diabetes (either Type 1 or Type 2) or a significant likelihood of requiring insulin treatment in the following 12 months or a HgbA1C \>= 9.
- Subjects with any serious health condition unrelated to their weight that would increase the risk of endoscopy
- Chronic abdominal pain
- Motility disorders of the GI tract such as gross esophageal motility disorders, gastroparesis or intractable constipation
- +17 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- University of Texascollaborator
- Johns Hopkins Universitycollaborator
- Brigham and Women's Hospitalcollaborator
- Endeavor Healthcollaborator
- University of Chicagocollaborator
- Orlando Health, Inc.collaborator
- Cornell Universitycollaborator
- Avera McKennan Hospital & University Health Centercollaborator
Study Sites (9)
Orlando Health
Orlando, Florida, 32806, United States
University of Chicago
Chicago, Illinois, 60637, United States
NorthShore University Health System
Evanston, Illinois, 60201, United States
Johns Hopkins University
Baltimore, Maryland, 21224, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
Cornell University
New York, New York, 10065, United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105, United States
University of Texas
Houston, Texas, 77401, United States
Related Publications (2)
Vargas EJ, Rizk M, Gomez-Villa J, Edwards PK, Jaruvongvanich V, Storm AC, Acosta A, Lake D, Fidler J, Bharucha AE, Camilleri M, Abu Dayyeh BK. Effect of endoscopic sleeve gastroplasty on gastric emptying, motility and hormones: a comparative prospective study. Gut. 2023 Jun;72(6):1073-1080. doi: 10.1136/gutjnl-2022-327816. Epub 2022 Oct 14.
PMID: 36241388DERIVEDAbu 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: 35908555DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Barham Abu Dayyeh
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Barham K Abu Dayyeh
Mayo Clinic
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Barham Abu Dayyeh, Principal Investigator
Study Record Dates
First Submitted
January 16, 2018
First Posted
January 23, 2018
Study Start
December 20, 2017
Primary Completion
October 29, 2020
Study Completion
October 15, 2021
Last Updated
October 18, 2022
Results First Posted
October 18, 2022
Record last verified: 2022-09