Evaluating MOTIlity, Hormonal Impact, Satiety, and Weight Changes With VArying Procedural TEchniques Utilizing the Incisionless Operating Platform for the Treatment of Primary Obesity
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Weight Loss
Study Overview
Brief Summary
The purpose of this study is to evaluate the impact of minor variations in Incisionless Operating Platform (IOP)procedural techniques on gastric emptying, hormone levels, satiety, and weight loss in the treatment of primary obesity. It will confirm, in an open prospective study, the action mechanisms for the "POSE" endoscopic treatment technique for obesity, and it will help determine if they are maintained at least 6 months following the procedure. Durability of weight loss will be tracked through post-POSE visits up to 18 months following the procedure.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Has a BMI of >30 and <40
- •Male or female ≥21 yrs. of age and < 60 yrs. of age at time of enrollment
- •Patient has had no significant weight change (+/- 5% of total body weight) in last 6 months but has been able to lose significant weight in the past with diet and exercise.
- •Is a reasonable candidate for general anesthesia
- •Agrees not to have any additional weight loss interventional procedures or liposuction for at least 18 months following study enrollment and agrees not to take any prescription or over the counter weight loss medications for at least 1 year.
- •Physically and mentally able to comply with the visit schedule, ancillary testing, and behavior modification (diet and exercise) required for the study and agrees to study commitment requirements
- •Had successful completion of the pre-screening, nutritional and educational programs and psychological assessment supporting that the subject is an appropriate bariatric surgical candidate
Exclusion Criteria
- •History of (or intra-operative evidence of) bariatric, gastric or esophageal surgery
- •Esophageal stricture or other anatomy and/or condition that could preclude passage of endoluminal instruments
- •Moderate to severe Gastro-esophageal reflux disease (GERD)
- •Known hiatal hernia >3cm by history or as determined by UGI exam or endoscopy
- •Known GI motility disorder or pancreatic insufficiency/disease
- •Intra-operative Exclusion: Active peptic ulcer or hiatal hernia >3cm
- •Present Corticosteroid Use
- •History of inflammatory disease of GI tract
- •Severe coagulopathies, hepatic insufficiency or cirrhosis
- •History or present use of insulin or insulin derivatives for treatment of diabetes
- •Had Type II Diabetes Mellitus (as defined by HgbA1c >6.0) for greater than 2 years at the time of enrollment
- •Uncontrolled Type II DM (HgbA1c >7.0 at screening)
- •Patient has quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
- •Patient has a history of drug or alcohol abuse or actively abusing either
- •Patient is presently being treated with medication for depression, psychosis, or other mood or eating disorder
- •Non-ambulatory or has significant impairment of mobility
- •Works for, or is first degree relative of investigator, study institution, or support staff involved in the study.
- •Known hormonal or genetic cause for obesity
- •Participating in another clinical study
- •Patient is on medications known to impact GI motility or gut hormones that cannot be discontinued prior to nuclear testing
- •Have work hours, family obligations or transportation issues that could interfere with patient returning for all scheduled evaluations, tests and nutritional counseling.
- •Lives >60 kilometers from investigator site.
- •Patient is not able to provide written informed consent
Arms & Interventions
Continuous Horizontal row
Use the IOP system from USGI to install suture anchors running from the distal body into the proximal antrum
Intervention: Using The IOP system from USGI to place suture anchors (Device)
Reduction in "ring" opening
Use the IOP system from USGI to install suture anchors to reduce the "ring" opening to the antrum
Intervention: Using The IOP system from USGI to place suture anchors (Device)
Control Arm
Use the IOP system from USGI to install suture anchors in the Current V shape in distal body
Intervention: Using The IOP system from USGI to place suture anchors (Device)
Outcomes
Primary Outcomes
Weight Loss
Time Frame: Monthly post procedure out to 18 months
Each patient's weight will be measured and recorded on a monthly basis out to 18 months post procedure
Secondary Outcomes
- Fasting/Post-prandial Peptides(pre-procedure & 8 weeks post procedure)