MOTIVATE Weight Loss Study

NCT01679158 | Completed DMC

• 1 other identifier: TPR600
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Using POSE as a treatment for Obesity

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Each patient's weight will be measured and recorded on a monthly basis out to 18 months post procedure

  Monthly post procedure out to 18 months

Secondary Outcomes (1)

• Fasting/Post-prandial Peptides

  pre-procedure & 8 weeks post procedure

Other Outcomes (2)

• Gastric Emptying

  Pre-procedure & 2 & 6 months post procedure

• Satiety Testing

  Pre-procedure & 2 & 6 months post procedure

Study Arms (3)

Continuous Horizontal row

EXPERIMENTAL

Use the IOP system from USGI to install suture anchors running from the distal body into the proximal antrum

Device: Using The IOP system from USGI to place suture anchors

Reduction in "ring" opening

EXPERIMENTAL

Use the IOP system from USGI to install suture anchors to reduce the "ring" opening to the antrum

Device: Using The IOP system from USGI to place suture anchors

Control Arm

EXPERIMENTAL

Use the IOP system from USGI to install suture anchors in the Current V shape in distal body

Device: Using The IOP system from USGI to place suture anchors

Interventions

Using The IOP system from USGI to place suture anchors DEVICE

Sutures are placed in the distal body in one of three randomized techniques: "A" = reduction in "ring" opening to antrum using plications "B" = continuous horizontal row, running from distal body into proximal antrum "C" = Control. Current V shape as Control

Also known as: The g-Cath EZ Suture Anchor Delivery Catheter

Continuous Horizontal row; Control Arm; Reduction in "ring" opening

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy.
• 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

Sponsors & Collaborators

• USGI Medical: lead

Study Sites (1)

Centro Medico

Barcelona, Catalonia, 08022, Spain

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jorge C. Espinos, MD

  Centro Medico Teknon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2012
• First Posted: September 5, 2012
• Study Start: February 1, 2012
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

ES (1)