Clinical trial

Endoscopic Metabolic and Bariatric Therapies

Invitation only · Not applicable · 1 countries · Registry ID NCT05725967

Invitation onlyNot applicableObservational

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 80 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, 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

Full registry criteria

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

Treatments and study arms

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.

Primary outcomes

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.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Brigham and Women's Hospital🇺🇸 Boston, Massachusetts, United States

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