Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)

Not Applicable

Completed

Conditions: Obesity
Diabetes Mellitus, Type 2
Hypertension

Interventions: Device: Overstitch Endoscopic Suture System
Behavioral: Lifestyle Intervention

Registration Number: NCT03406975

Lead Sponsor: Mayo Clinic

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 208

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Crossover Group: Lifestyle Intervention to ESG Procedure	Overstitch Endoscopic Suture System	Control 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.
Control Group: Lifestyle Modification	Lifestyle Intervention	Participants 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	Overstitch Endoscopic Suture System	Participants 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	Lifestyle Intervention	Control 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.
Treatment Group: Overstitch ESG Procedure	Lifestyle Intervention	Participants 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

Primary Outcome Measures

Name	Time	Method
Percentage of Excess Weight Loss (EWL)	12 months	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)

Secondary Outcome Measures

Name	Time	Method
Number of Participants With ≥25% EWL	12 months	Total number of participants with ≥25% excess weight loss at 12 months from randomization
Change in Blood Pressure for ESG Intervention From Baseline to 24 Months	Baseline, 24 months	Change in blood pressure for participants that received ESG intervention measured in units of millimeters of mercury (mmHg)
Number of Participants Off or With Reduction in Diabetes Medications	12 months	Total number of participants off or with reduction in diabetes medications
Change in HgbA1c	Baseline, 12 months	Change in HgbA1c levels
Change in HgbA1c for ESG Intervention From Baseline to 24 Months	Baseline, 24 months	Change in HgbA1c levels for participants that received the ESG intervention
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite)	Baseline, 12 months	Changes in impact of weight on quality of life score assessed using self-reported IWQOL-lite questionnaire consisting of five domains: physical function (11 items, score range from 11-55 with higher scores indicating more negative outcome), self-esteem (7 items, score range from 7-35 with higher scores indicating more negative outcome), sexual life (4 items, score range from 4-20 with higher scores indicating more negative outcome), public distress (5 items, score range from 5-25 with higher scores indicating more negative outcome), and work (4 items, score range from 4-20 with higher scores indicating more negative outcome).
Number of Participants With Major Depression or Severe Major Depression at 12 Months	12 months	Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score \< 10; major depression, 10 ≤ score \< 20; severe major depression, x ≥ 20
Change in Eating Behaviors	Baseline, 12 months	Change in eating behaviors evaluated using the self-reported Three Factor Eating Questionnaire (TFEQ) consisting of 3 domains: cognitive restraint (6-items, score range from 0-100 with higher score indicating more restraint), uncontrolled eating (9-items, score range from 0-100 with lower score indicating more control), and emotional eating (3-items, score range 0-100 with higher score indicating eating with negative emotions)
Number of Participants Off Or With Reduction in Antihypertensive Medications	12 months	Total number participants off or with reduction in antihypertensive medications
Change in Blood Pressure	Baseline, 12 months	Change in blood pressure measured in units of millimeters of mercury (mmHg)
Percentage of Total Body Weight Loss (TBWL)	12 months	Percentage of total body weight loss in participants
Number of Participants to Achieve ≥5% TBWL	12 months	Total number of participants to achieve ≥5% total body weight loss
Changes in Health Status Survey Scores	Baseline, 12 months	Changes in subject's view of health assessed using self-reported SF-36 Health Status Survey consisting of 8 scaled scores: physical function (10-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to physical health (4-items, score range from 0-100 with higher scores indicating more positive outcome), role limitations due to emotional problems (3-item, score range from 0-100 with higher scores indicating more positive outcome), energy/fatigue (4-items, score range from 0-100 with higher scores indicating more positive outcome), emotional well-being (5-items, score range from 0-100 with higher scores indicating more positive outcome), social functioning (2-items, score range from 0-100 with higher scores indicating more positive outcome), pain (2-items, score range from 0-100 with higher scores indicating more positive outcome), general health (5-items, score range from 0-100 with higher scores indicating more positive outcome)
Number of Participants to Achieve ≥10% TBWL	12 months	Total number of participants to achieve ≥10% total body weight loss
Esophagitis at Repeat Endoscopy	12 months	Total number of participants to have esophagitis at repeat endoscopy
Number of Participants With Major Depression or Severe Major Depression at Baseline	Baseline	Number of participants to identify with major or severe major depression measured using the self-reported Patient Health Questionnaire (PHQ-9). The PHQ-9 is self-reported 9-item questionnaire to assess degree of depression severity with total score range from 0-27 categories were defined as followed: minimal, score \< 10; major depression, 10 ≤ score \< 20; severe major depression, x ≥ 20

Trial Locations

Locations (9): Avera McKennan Hospital & University Health Center
🇺🇸
Sioux Falls, South Dakota, United States
Cornell University
🇺🇸
New York, New York, United States
Orlando Health
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Orlando, Florida, United States
University of Chicago
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Chicago, Illinois, United States
NorthShore University Health System
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Evanston, Illinois, United States
Johns Hopkins University
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Baltimore, Maryland, United States
Brigham and Women's Hospital
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Boston, Massachusetts, United States
Mayo Clinic in Rochester
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Rochester, Minnesota, United States
University of Texas
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Houston, Texas, United States