Endoscopic Metabolic and Bariatric Therapies

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Christopher C. Thompson, MD, MSc
Study ID
NCT05725967
Status
Enrolling By Invitation

Conditions

  • Abdominal Obesity
  • Abdominal Pain
  • Bariatric Surgery Candidate
  • Complication of Surgical Procedure
  • Complication of Treatment
  • Complication,Postoperative
  • Delayed Gastric Emptying Following Procedure
  • Fistula, Gastric
  • Leak, Anastomotic
  • Obesity
  • Obesity Associated Disorder
  • Obesity, Morbid
  • Roux-en-y Anastomosis Site
  • Ulcer, Gastric
  • Weight Gain
  • Weight Loss

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Primary Obesity Endoscopic Procedures — PROCEDURE
    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 Procedures — PROCEDURE
    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 Procedures — PROCEDURE
    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 Reduction — DEVICE
    Any endoscopic procedure using an endoscopic suturing device for primary obesity treatment or revision of post bariatric complications.
  • Intragastric Balloon — DEVICE
    An endoscopic bariatric procedure involving the placement of an intragastric balloon.
  • Primary obesity surgery endoluminal, Restorative obesity surgery endoluminal — DEVICE
    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 Myotomy — DEVICE
    Electrosurgical interventions for obesity. Use of electrosurgical devices, such as electrocautery for the primary treatment of obesity or obesity related complications.
  • Aspiration Therapy — DEVICE
    Placement of an aspiration therapy device for the treatment of obesity.

Study Details

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.

Key Dates

Start date
Jul 8, 2022
Status verified
Nov 2025
Primary completion
May 28, 2028
Completion
May 28, 2029

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: Primary Obesity Endoscopic Procedures
    Primary endoscopic procedures for treatment of obesity.
  • Arm: Endoscopic Revision of Bariatric Surgical Procedures
    Endoscopic revision of post-bariatric surgical complications.
  • Arm: Bariatric Surgery Procedures
    Bariatric surgical procedures.

Primary Outcome Measure

Change in weight from pre-procedure to 10 years [ Time Frame: Baseline, 3 months, 6 months, 9 months, 12 months, years 1-10. ]

Locations (1)

FacilityCityStateZIPSite coordinators
Brigham and Women's HospitalBostonMassachusetts02115-

Find similar trials in Boston, MA

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Brigham and Women's Hospital· Boston, MA

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