ULTIMATE Study for Weight Loss

NCT01771276 | Completed DMC

• 1 other identifier: TPR602
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to help find out more about how the Primary Obesity Surgery Endoluminal (POSE) procedure makes patients feel less hungry and fuller faster, leading to weight loss. In this study, USGI Medical wants to see if stomach emptying and gastro-intestinal hormone levels change after a POSE procedure with an increased (as compared to typical) number of anchors placed.

Conditions

Obesity

Keywords

POSE

Outcome Measures

Primary Outcomes (1)

• Weight Loss

  Weight loss will be monitored and recorded on a monthly basis for up to 18 months post POSE with the proportion of subjects achieving ≥25% excess weight loss (EWL) at 12 months (Met Life criteria)being the primary efficacy endpoint

  18 months

Secondary Outcomes (1)

• Gastric emptying

  Immediately Pre-procedure, & 2 & 6 months post procedure

Other Outcomes (2)

• Satiety

  Immediately Pre-procedure, & 2 & 6 months post procedure

• Peptide Measurements

  Immediately Pre-procedure & 2 Months post procedure

Study Arms (1)

Ultimate Anchor

EXPERIMENTAL

Use of the g-Cath Suture Anchor Delivery Catheter and accessories in placing the ultimate number of anchors for weight loss.

Device: g-Cath Suture Anchor Delivery Catheter

Interventions

g-Cath Suture Anchor Delivery Catheter DEVICE

Evaluate changes in emptying, hormones, satiety and weight loss with use of the g-Cath Suture Anchor Delivery Catheter in maximizing g-Cath Suture Anchor placement to as high as 25 anchors.

Ultimate Anchor

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 endolumenal 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 Teknon

Barcelona, 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: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: January 18, 2013
• Study Start: June 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

ES (1)