Endoscopic Metabolic and Bariatric Therapies (EMBTs)

November 25, 2025 updated by: Christopher C. Thompson, MD, MSc
This is a prospective collection of data from adult patients who have had an endoscopic metabolic and bariatric endoscopy procedure (EMBT) for primary or revision surgical procedures for obesity.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The Investigators will be collecting data on bariatric patients post-bariatric surgery, post-endoscopic revision of bariatric surgical complications and post-endoscopic metabolic and bariatric therapies (including but not limited to roux-en-y gastric bypass, sleeve gastrectomy, laparoscopic adjustable gastric banding, gastroplasty with endoscopic myotomy (GEM), endoscopic sleeve gastroplasty (ESG), transoral outlet reduction (TORe), primary obesity surgery endoluminal (POSE), restorative obesity surgery endoluminal (ROSE), intragastric balloons (IGB), aspiration therapy and pylorus sparing antral myotomy) to review demographics, adverse events, medications, radiology, procedure time, cost, comorbidity resolution and resource utilization.

Study Type

Observational

Enrollment (Estimated)

5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients registered with Mass General Brigham affiliate facilities who have undergone an endoscopic primary obesity procedure, an endoscopic bariatric revision procedure, or a bariatric surgical procedure.

Description

Inclusion Criteria:

  • patients from Mass General Brigham
  • any patient having an endoscopic primary obesity procedure
  • any patient having an endoscopic post-bariatric surgical revision procedure
  • any patient having a bariatric surgical procedure

Exclusion Criteria:

  • patients without past surgical and medical history medical records in the Mass General Brigham system
  • patients unwilling to allow for medical record review at Mass General Brigham

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Primary Obesity Endoscopic Procedures
Primary endoscopic procedures for treatment of obesity.
Procedure: Primary Obesity Endoscopic Procedures
Any primary endoscopic procedure for treatment of obesity including endoscopic sleeve gastroplasty (ESG), intragastric balloons (IGB), Aspiration therapy, pylorus sparing antral myotomy (PSAM), primary obesity surgery endoluminal (POSE), gastroplasty with endoscopic myotomy (GEM).
Other Names:
  • ESG, Aspiration Therapy, IGB, POSE, GEM, PSAM, BEAM, EMBTs
Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction
Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.
Other Names:
  • ESG, TORe
Device: Intragastric Balloon
An endoscopic bariatric procedure involving the placement of an intragastric balloon.
Other Names:
  • IGB
Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal
Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.
Other Names:
  • POSE, ROSE
Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy
Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.
Other Names:
  • APC, GEM, BEAM, PSAM
Device: Aspiration Therapy
Placement of an aspiration therapy device for the treatment of obesity.
Other Names:
  • Aspire
Endoscopic Revision of Bariatric Surgical Procedures
Endoscopic revision of post-bariatric surgical complications.
Device: Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction
Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.
Other Names:
  • ESG, TORe
Device: Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal
Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.
Other Names:
  • POSE, ROSE
Device: Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral Myotomy
Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.
Other Names:
  • APC, GEM, BEAM, PSAM
Procedure: Endoscopic Revision of Bariatric Surgical Procedures
Any endoscopic revision procedure in a post-bariatric surgical patient, including transoral outlet reduction (TORe), restorative obesity surgery endoluminal (ROSE), argon plasma coagulation of the outlet (APC), endoscopic suturing.
Other Names:
  • TORe, ROSE, APC
Bariatric Surgery Procedures
Bariatric surgical procedures.
Procedure: Bariatric Surgery Procedures
Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)
Other Names:
  • RYGB, LSG, LAGB

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in weight from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
%TBWL
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change of HgA1c (%) by comparing lab values from baseline through 10 years.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in total cholesterol measurements by comparing followup lab values (mg/dL) to baseline.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 years
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in rate of adverse events from procedure to 10 years
Time Frame: Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in rate of adverse events post-procedure through 10 years
Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in comorbidity medication dosages from baseline to 10 years
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change of dosage of comorbidity medications compared to baseline
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in hypertension from pre-procedure to 10 years using blood pressure measurements
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in hypertension from pre-procedure to 10 years using medication dosages
Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.
Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in gastric motility from baseline to 10 years
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Gastric emptying breath test
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in PYY gut hormones from baseline to 10 years
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
PYY lab values will be compared to baseline
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in GLP1 gut hormones from baseline to 10 years
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
GLP1 lab values will be compared to baseline
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Change in ghrelin hormones from baseline to 10 years
Time Frame: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Ghrelin lab values will be compared to baseline
Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.
Cost comparison of procedural costs associated with bariatric endoscopic vs. surgical procedures from baseline to 10 years
Time Frame: Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery
Cost-effectiveness analysis of procedure costs from admission to discharge for endoscopic vs. surgical bariatric procedures
Pre-intervention/procedure/surgery, during the procedure/surgery, immediately after the intervention/procedure/surgery, up to 3 months after the intervention/procedure/surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Christopher C. Thompson, MD, MSc

Investigators

  • Principal Investigator: Christopher C. Thompson, MD, MSc, Brigham and Women's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2022

Primary Completion (Estimated)

May 28, 2028

Study Completion (Estimated)

May 28, 2029

Study Registration Dates

First Submitted

December 29, 2022

First Submitted That Met QC Criteria

February 10, 2023

First Posted (Actual)

February 13, 2023

Study Record Updates

Last Update Posted (Actual)

December 2, 2025

Last Update Submitted That Met QC Criteria

November 25, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P001757

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Depending on the range of data and publication status, the PI will consider de-identified data sharing with a data transfer agreement in place after discussion of parameters and study design.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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