Endoscopic Metabolic and Bariatric Therapies

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 18 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Conditions

Obesity, Obesity, Morbid, Obesity Associated Disorder, Bariatric Surgery Candidate, Fistula, Gastric, Roux-en-y Anastomosis Site

Being tested

Primary Obesity Endoscopic Procedures, Endoscopic Revision of Bariatric Surgical Procedures, Bariatric Surgery Procedures, Endoscopic Sleeve Gastroplasty, Trans-oral Outlet Reduction, Intragastric Balloon

Keywords

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, pylorus sparing antral myotomy (PSAM), gastric emptying breath test (GEBT)

Medical subject headings

Obesity, Obesity, Morbid, Gastric Fistula, Stomach Ulcer, Abdominal Pain, Obesity, Abdominal, Postoperative Complications, Weight Gain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Primary Obesity Endoscopic ProceduresProcedure or surgery

  Also called ESG, Aspiration Therapy, IGB, POSE, GEM, PSAM, BEAM, EMBTs

  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).

• Endoscopic Revision of Bariatric Surgical ProceduresProcedure or surgery

  Also called TORe, ROSE, APC

  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.

• Bariatric Surgery ProceduresProcedure or surgery

  Also called RYGB, LSG, LAGB

  Any bariatric surgical procedure including Roux-en-Y gastric bypass (RYGB), laparoscopic sleeve gastroplasty (LSG), laparoscopic adjustable gastric banding (LAGB)

• Endoscopic Sleeve Gastroplasty, Trans-oral Outlet ReductionDevice

  Also called ESG, TORe

  Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.

• Intragastric BalloonDevice

  Also called IGB

  An endoscopic bariatric procedure involving the placement of an intragastric balloon.

• Primary obesity surgery endoluminal, Restorative obesity surgery endoluminalDevice

  Also called POSE, ROSE

  Any endoscopic procedure using an endoscopic plicating device for primary obesity treatment or revision of post bariatric complications.

• Argon Plasma Coagulation, Gastroplasty with Endoscopic Myotomy, Bariatric Endoscopic Antral Myotomy, Pylorus Sparing Antral MyotomyDevice

  Also called APC, GEM, BEAM, PSAM

  Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.

• Aspiration TherapyDevice

  Also called Aspire

  Placement of an aspiration therapy device for the treatment of obesity.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Change in weight from pre-procedure to 10 years

   %TBWL

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

2. Change in hypertension from pre-procedure to 10 years using blood pressure measurements

   Change of hypertension status by comparing blood pressure measurements (systolic/diastolic mmHg) from baseline.

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

3. Change in hypertension from pre-procedure to 10 years using medication dosages

   Change of hypertension status by comparing change in dosage (mg) of hypertension medications from baseline.

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

4. Change in medication dosage to determine change in diabetes status from pre-procedure to 10 years

   Change of diabetes status by comparing change in dosage (mg) of diabetes medications from baseline to 10 years.

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

5. Change percent value of HgA1c to determine change in diabetes status from pre-procedure to 10 years

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

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

6. Change in total cholesterol lab values (mg/dL) from pre-procedure to 10 years

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

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

7. Change in low density lipoprotein (LDL) lab values (mg/dL) from pre-procedure to 10 years

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

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

8. Change in high density lipoprotein (HDL) lab values (mg/dL) from pre-procedure to 10 years

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

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

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

   Change in total cholesterol measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

   Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

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

    Change in HDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

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

    Change in LDL measurements by comparing change in dosage of cholesterol medications (mg) from baseline to 10 years.

    Measured: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10.

12. Change in rate of adverse events from procedure to 10 years

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

    Measured: Procedure, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

13. Change in comorbidity medication dosages from baseline to 10 years

    Change of dosage of comorbidity medications compared to baseline

    Measured: Baseline, 1 month, 3 months, 6 months, 9 months, 12 months, years 1-10.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted13 Feb 2023
2. Study start8 Jul 2022
3. Primary completion28 May 2028 (estimated)
4. Study completion28 May 2029 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Publications (12)Papers the sponsor has linked to this study.
• Other trials for ObesityStudies of the same condition, open and under way.
• 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.