Endoscopic Suturing for Primary Obesity Treatment (PROMISE)

Mass General Brigham

Status

Completed

Conditions

Overweight

Obesity

Body Weight

Treatments

Device: Endoscopic gastric restrictive procedure

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01662024

2012P-000799

Details and patient eligibility

About

Gastric restriction is an important principle of both roux-en-Y gastric bypass and laparoscopic adjustable gastric banding. The FDA cleared OverStitch Endoscopic Suturing System (Apollo Endosurgery, Austin, TX) offers the physician the ability to restrict gastric size by approximating tissue endoluminally via an incisionless/per-oral approach. The use of this system has the potential to reduce the complications associated with current surgical approaches while effecting the desired gastric restriction. The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.

Full description

The primary objective is to collect data on the use of the OverStitch Endoscopic Suturing System (Apollo Endosurgery, Inc. Austin, Texas) for gastric tissue approximation during primary gastric restrictive procedures.

The primary endpoint of this study is evaluation of safety and feasibility of the procedure. All subjects for whom the plication procedure is initiated (defined as placement of the overtube) will be included in the safety analysis. The primary safety analysis will assess the occurrence of adverse events through 12 months after the plication procedure.

Technical success will be defined as minimum placement of 8 sutures upon initial endoscopic intervention. Safety will be determined as no adverse events directly related to the procedure at 12 months.

Secondary Endpoints:

Efficacy: Data for the following effectiveness outcome measures (variables) will be collected and analyzed relative to baseline:
- Percent excess weight loss (%EWL)
- Total weight lost (kg) and percent weight lost
- Change in (BMI) and percent change in BMI
- Change in waist circumference
- Improvement in co-morbid disease(s) including, but not limited to, improvement in vital signs and/or laboratory values
- Changes in quality of life measures as reported on Quality of Life questionnaire(s) (evaluated relative to baseline)
- Changes in feelings of satiety measures as reported on the TFEQ-R18 (relative to baseline)
Durability: Data will be collected on the durability of the plications by evaluating the remaining plications at the 12 month endoscopy, compared to the number of plications placed at the time of procedure.

Enrollment

20 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject has met diabetic lab testing and all pre-procedural qualifications
Subject is ≥ 18 yrs. of age and ≤ 60 yrs. of age
Subject has a BMI of > 30 and < 35
Subject has history of obesity for > 2 yrs
Subject has had no significant weight change (<5% of total body weight)in last 6 months
Subject must have failed standard obesity therapy of diet, exercise, behavior modification, and pharmacologic agents either alone or in combination, as assessed by an interview with a member of the study team at baseline
Subject is a reasonable candidate for general anesthesia
Subject agrees not to have any additional weight loss surgery or reconstructive surgery that may affect body weight (i.e. mammoplasty, liposuction, lipoplasty, etc) during the trial
Subject must be willing and able to participate in all aspects of the study and agree to comply with all study requirements for the duration of the study. This includes availability of reliable transportation and sufficient time to attend all follow-up visits.
Subject must be able to fully understand and be willing to sign the informed consent

Exclusion criteria

Subject has had significant weight loss in the last 3 months, or between baseline and the study procedure
Mallampati (intubation) score greater than 3
Subject is observed during EGD to have heavily scarred, malignant or poor quality/friable tissue in areas of the stomach where sutures are to be placed
Subject has history or present use of insulin or insulin derivatives for treatment of diabetes
Subject has diabetes secondary to a specific disease
Subject has poorly controlled diabetes as indicated by the lack of stable diabetes medications and doses over the last month, or has a history of diabetes for greater than 10 years
Subject has history of inflammatory disease of GI tract
Subject has a history of intestinal strictures or adhesions
Subject has renal and/or hepatic insufficiency
Subject has chronic pancreatic disease
Subject has history of/or signs and/or symptoms of gastro-duodenal ulcer disease and/or active peptic ulcer
Subject has significant esophageal disease including Zenker's diverticulum, grade 3-4 reflux esophagitis, stricture, Barrett's esophagus, esophageal cancer, esophageal diverticulum, dysphagia, achalasia, or symptoms of dysmotility
Subject has a history of any significant abdominal surgery
Subject has had previous bariatric, gastric or esophageal surgery; intestinal obstruction; portal gastropathy; gastrointestinal tumors; esophageal or gastric varices, or gastroparesis
Subject has a hiatal hernia > 2cm
Subject has chronic/acute upper GI bleeding conditions
Subject has severe coagulopathy (prothrombin time > 3 seconds over control or platelet count < 100,000) or is presently taking heparin, coumadin, warfarin, or other anticoagulants or other medications which impede coagulation or platelet aggregation
Female subject is of childbearing age and not practicing effective birth control, is pregnant or is lactating
Subject has symptomatic congestive heart failure, cardiac arrhythmia or unstable coronary artery disease.
Subject has cancer or life expectancy of < 2 yrs
Subject has systemic infection in the body at the time of the plication procedure.
Subject currently uses or has used over the counter or prescription weight loss medications in last 30 days or intends to use during follow-up Study period.
Subjects who have started medications within the last 3 months that are known to cause weight gain
Subjects undergoing chronic steroid therapy
Subjects undergoing immunosuppressive therapy
Subject has a history of drug or alcohol abuse
Subject has a history of uncontrolled or poorly controlled psychiatric disease or suspected eating disorders
Subject is non-ambulatory or has significant impairment of mobility
Subject has known hormonal or genetic cause for obesity
Subject is not in sufficient and stable medical health, as determined and evaluated by the Principal Investigator.
Subject has participated in a clinical study with an investigational new drug, biological, or therapeutic device within ≤ 28 days prior to enrollment in this study, and does not agree to abstain from participation in other clinical trials of any kind during this study