N/A
N=20
Endoscopic Suturing for Primary Obesity Treatment
Obesity · Body Weight · Overweight
Bottom Line
View on ClinicalTrials.gov: NCT01662024 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcome: Primary: Number of Participants With Adverse Events — 5; 2; 0; 13 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Endoscopic gastric restrictive procedure (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Brigham and Women's Hospital
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events |
5; 2; 0; 13 | — |
| PRIMARY Evaluation of Technical Feasibility of the Procedure |
10.4; 54.4; 4 | — |
| SECONDARY Percent Excess Weight Loss |
70.8 | — |
| SECONDARY Durability |
— | — |
| SECONDARY Percentage of Total Body Weight Loss |
18.1 | — |
| SECONDARY BMI Loss (kg/m^2) |
6.1 | — |
| SECONDARY Waist Circumference Loss (cm) |
16 | — |
Summary
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.
Eligibility Criteria
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 2 yrs
- Subject has had no significant weight change ( 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
Data sourced from ClinicalTrials.gov (NCT01662024). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.