NCT05725967

Endoscopic Metabolic and Bariatric Therapies

Enrolling by Invitation
Not specifiedAges 18–80Observational
Christopher C. Thompson, MD, MSc
~5,000 participants
Updated 2025-12-02 on ClinicalTrials.gov
What's tested:Primary Obesity Endoscopic ProceduresEndoscopic Revision of Bariatric Surgical ProceduresBariatric Surgery ProceduresEndoscopic Sleeve Gastroplasty, Trans-oral Outlet ReductionIntragastric BalloonPrimary obesity surgery endoluminal, Restorative obesity surgery endoluminal

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in weight from pre-procedure to 10 years
Measured over Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.
+12 more outcomes measured
Obesity
Obesity, Morbid
Obesity Associated Disorder
Bariatric Surgery Candidate
Fistula, Gastric
Roux-en-y Anastomosis Site
Ulcer, Gastric
Abdominal Pain
Abdominal Obesity
Complication of Surgical Procedure
Complication of Treatment
Complication,Postoperative
Weight Gain
Weight Loss
Leak, Anastomotic
Delayed Gastric Emptying Following Procedure
1 sites across 1 states
Massachusetts1
  • Christopher C. Thompson, MD, MSc · PRINCIPAL_INVESTIGATOR · Brigham and Women's Hospital

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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
  • Change in weight from pre-procedure to 10 yearsBaseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    %TBWL

  • Change in hypertension from pre-procedure to 10 years using blood pressure measurementsBaseline, 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.

  • Change in hypertension from pre-procedure to 10 years using medication dosagesBaseline, 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.

  • Change in medication dosage to determine change in diabetes status from pre-procedure to 10 yearsBaseline, 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.

  • Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 yearsBaseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change of HgA1c (%) by comparing lab values from baseline through 10 years.

  • Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 yearsBaseline, 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.

  • Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 yearsBaseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in LDL measurements by comparing followup lab values (mg/dL) to baseline.

  • Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 yearsBaseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in HDL measurements by comparing followup lab values (mg/dL) to baseline.

  • Change in medication dosage (mg) to determine change in total cholesterol (mg/dL) from pre-procedure to 10 yearsBaseline, 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.

  • Change in medication dosage (mg) to determine change in High Density Lipoprotein (HDL) (mg/dL) from pre-procedure to 10 yearsBaseline, 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.

  • Change in medication dosage (mg) to determine change in Low Density Lipoprotein (LDL) (mg/dL) from pre-procedure to 10 yearsBaseline, 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.

  • Change in rate of adverse events from procedure to 10 yearsProcedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change in rate of adverse events post-procedure through 10 years

  • Change in comorbidity medication dosages from baseline to 10 yearsBaseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

    Change of dosage of comorbidity medications compared to baseline