ObesityNCT03406975
Multicenter Endoscopic Sleeve Gastrectomy (ESG) Trial (MERIT Trial)
A study testing Overstitch Endoscopic Suture System and Lifestyle Intervention in people with Obesity and Hypertension, run by Mayo Clinic at 9 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Hypertension, Diabetes Mellitus, Type 2
- What is being tested?
- Overstitch Endoscopic Suture System and Lifestyle Intervention
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 208 participants
- Where
- 9 sitesUnited States
- Study dates
- 20 Dec 2017to 15 Oct 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
Show all 32Show fewer
- 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
- Hepatic insufficiency or cirrhosis
- Use of an intragastric device prior to this study due to the increased thickness of the stomach wall preventing effective suturing.
- Active psychological issues preventing participation in a life-style modification program as determined by a psychologist
- Patients unwilling to participate in an established medically-supervised diet and behavior modification program, with routine medical follow-up.
- Patients receiving daily prescribed treatment with high dose aspirin (> 80mg daily), anti-inflammatory agents, anticoagulants or other gastric irritants.
- Patients who are unable or unwilling to take prescribed proton pump inhibitor medication
- Patients who are pregnant or breast-feeding.
- Subjects with Severe cardiopulmonary disease or other serious organic disease which might include known history of coronary artery disease, Myocardial infarction within the past 6 months, poorly-controlled hypertension, required use of NSAIDs
- Subjects taking medications on specified hourly intervals that may be affected by changes to gastric emptying, such as anti-seizure or anti-arrhythmic medications
- Subjects who are taking corticosteroids, immunosuppressants, and narcotics
- Subjects who are taking diet pills
- Symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
- Pre-existing respiratory disease such as chronic obstructive pulmonary disease (COPD), pneumonia or cancer.
- Diagnosis of autoimmune connective tissue disorder (e.g. lupus, erythematous, scleroderma) or immunocompromised.
- Specific diagnosed genetic disorder such as Prader Willi syndrome.
- Eating disorders including night eating syndrome (NES), bulimia, binge eating disorder, or compulsive overeating
- Known history of endocrine disorders affecting weight such as uncontrolled hypothyroidism.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Johns Hopkins University
Baltimore, Maryland, 21224
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Chicago
Chicago, Illinois, 60637
NorthShore University Health System
Evanston, Illinois, 60201
University of Texas
Houston, Texas, 77401
Cornell University
New York, New York, 10065
Orlando Health
Orlando, Florida, 32806
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105
About this study
Official title: Multi-center ESG Randomized Interventional Trial (MERIT-Trial)
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.
- Conditions
- Obesity, Hypertension, Diabetes Mellitus, Type 2
- Being tested
- Overstitch Endoscopic Suture System, Lifestyle Intervention
- Medical subject headings
- Obesity, Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Overstitch Endoscopic Suture SystemDevice
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.
Lifestyle InterventionBehavioural
Standard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months.
| Study group | Role | What they receive |
|---|---|---|
| Control Group: Lifestyle Modification | Active comparator | 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. Receives: Behavioral: Lifestyle Intervention |
| Treatment Group: Overstitch ESG Procedure | Experimental | 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 Receives: Device: Overstitch Endoscopic Suture System; Behavioral: Lifestyle Intervention |
| Crossover Group: Lifestyle Intervention to ESG Procedure | Experimental | 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. Receives: Device: Overstitch Endoscopic Suture System; Behavioral: Lifestyle Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Secondary outcomes (16)
Number of Participants With ≥25% EWL
Total number of participants with ≥25% excess weight loss at 12 months from randomization
Measured: 12 months
Number of Participants Off Or With Reduction in Antihypertensive Medications
Total number participants off or with reduction in antihypertensive medications
Measured: 12 months
Change in Blood Pressure
Change in blood pressure measured in units of millimeters of mercury (mmHg)
Measured: Baseline, 12 months
Change in Blood Pressure for ESG Intervention From Baseline to 24 Months
Change in blood pressure for participants that received ESG intervention measured in units of millimeters of mercury (mmHg)
Measured: Baseline, 24 months
Number of Participants Off or With Reduction in Diabetes Medications
Total number of participants off or with reduction in diabetes medications
Measured: 12 months
Change in HgbA1c
Change in HgbA1c levels
Measured: Baseline, 12 months
Change in HgbA1c for ESG Intervention From Baseline to 24 Months
Change in HgbA1c levels for participants that received the ESG intervention
Measured: Baseline, 24 months
Percentage of Total Body Weight Loss (TBWL)
Percentage of total body weight loss in participants
Measured: 12 months
Number of Participants to Achieve ≥5% TBWL
Total number of participants to achieve ≥5% total body weight loss
Measured: 12 months
Number of Participants to Achieve ≥10% TBWL
Total number of participants to achieve ≥10% total body weight loss
Measured: 12 months
Esophagitis at Repeat Endoscopy
Total number of participants to have esophagitis at repeat endoscopy
Measured: 12 months
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
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).
Measured: Baseline, 12 months
Changes in Health Status Survey Scores
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)
Measured: Baseline, 12 months
Number of Participants With Major Depression or Severe Major Depression at 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
Measured: Baseline
Number of Participants With Major Depression or Severe Major Depression at 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
Measured: 12 months
Change in Eating Behaviors
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)
Measured: Baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2018
- Study start20 Dec 2017
- Primary completion29 Oct 2020
- Study completion15 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Texas, Johns Hopkins University, Brigham and Women's Hospital, Endeavor Health, University of Chicago, Orlando Health, Inc., Cornell University, Avera McKennan Hospital & University Health Center
- Responsible party
- Principal investigator, Barham K. Abu Dayyeh, M.D., Mayo Clinic
- Investigators
- Barham K Abu Dayyeh, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03406975
- Sponsor's protocol ID
- 17-007934
- Status last verified
- Sep 2022
- First submitted
- 16 Jan 2018
- Last updated
- 18 Oct 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
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.
PubMed 36241388Abu 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 35908555
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center ESG Randomized Interventional Trial (MERIT-Trial)
- ClinicalTrials.gov ID
- NCT03406975
- Acronym / sponsor ID
- 17-007934
- Conditions
- Obesity, Hypertension, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- University of Texas, Johns Hopkins University, Brigham and Women's Hospital, Endeavor Health, University of Chicago, Orlando Health, Inc., Cornell University, Avera McKennan Hospital & University Health Center
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 15 Oct 2021 (actual)
- First posted
- 23 Jan 2018 (actual)
- Results
- Posted 18 Oct 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control Group: Lifestyle Modification | Active comparator | Behavioral: Lifestyle InterventionParticipants 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 | Experimental | Device: Overstitch Endoscopic Suture System, Behavioral: Lifestyle InterventionParticipants 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 | Experimental | Device: Overstitch Endoscopic Suture System, Behavioral: Lifestyle InterventionControl 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (32 listed)
- 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.
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 |
|---|---|---|
| Overstitch Endoscopic Suture SystemEndoscopic 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. | Device | Crossover Group: Lifestyle Intervention to ESG Procedure, Treatment Group: Overstitch ESG Procedure |
| Lifestyle InterventionStandard low-calorie diet plan and moderate intensity life-style intervention of 150 minutes of aerobic exercise per week for 12 months. | Behavioural | Control Group: Lifestyle Modification, Crossover Group: Lifestyle Intervention to ESG Procedure, Treatment Group: Overstitch ESG Procedure |
Primary outcome
Percentage of Excess Weight Loss (EWL)
Time frame: 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)
16 secondary outcomes
Number of Participants With ≥25% EWL
Time frame: 12 months
Number of Participants Off Or With Reduction in Antihypertensive Medications
Time frame: 12 months
Change in Blood Pressure
Time frame: Baseline, 12 months
Change in Blood Pressure for ESG Intervention From Baseline to 24 Months
Time frame: Baseline, 24 months
Number of Participants Off or With Reduction in Diabetes Medications
Time frame: 12 months
Change in HgbA1c
Time frame: Baseline, 12 months
Change in HgbA1c for ESG Intervention From Baseline to 24 Months
Time frame: Baseline, 24 months
Percentage of Total Body Weight Loss (TBWL)
Time frame: 12 months
Number of Participants to Achieve ≥5% TBWL
Time frame: 12 months
Number of Participants to Achieve ≥10% TBWL
Time frame: 12 months
Esophagitis at Repeat Endoscopy
Time frame: 12 months
Change in Impact of Weight on Quality of Life-Lite (IWQOL-Lite)
Time frame: Baseline, 12 months
Changes in Health Status Survey Scores
Time frame: Baseline, 12 months
Number of Participants With Major Depression or Severe Major Depression at Baseline
Time frame: Baseline
Number of Participants With Major Depression or Severe Major Depression at 12 Months
Time frame: 12 months
Change in Eating Behaviors
Time frame: Baseline, 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36241388Vargas 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.
- Derived from this study: 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.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Barham K Abu Dayyeh principal investigator
Mayo Clinic
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Overstitch Endoscopic Suture System and Lifestyle Intervention in people with Obesity and Hypertension, run by Mayo Clinic at 9 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 9 inclusion and 32 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: finished, as of the sponsor's last update on 18 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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?
Yes. Results are posted in the registry (first posted 18 Oct 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Excess Weight Loss (EWL) (time frame: 12 months). 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 NCT03406975, which also lists 2 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 18 Oct 2022; AzTrials last refreshed its copy on 29 Oct 2026.