ULTIMATE Study for Weight Loss

NCT ID: NCT01771276

Last Updated: 2015-04-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2013-12-31

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.

Detailed Description

This study will use the USGI Medical Incisionless Operating Platform (IOP) to determine the affects of placing more Suture Anchors per patient (as compared to the current practice) in Primary Obesity Surgery Endoluminal(POSE). USGI wants to see if placing more anchors (particularly in the distal body/antrum region) significantly impacts primary weight loss, satiety, and metabolic outcomes.

Conditions

Obesity

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ultimate Anchor

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

Group Type: EXPERIMENTAL

g-Cath Suture Anchor Delivery Catheter

Intervention Type: 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.

Interventions

g-Cath Suture Anchor Delivery Catheter

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.

Intervention Type: DEVICE

Eligibility Criteria

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 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
• Intra-operative Exclusion: Active peptic ulcer or hiatal hernia >3cm
• 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
• 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

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

USGI Medical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jorge C Espinos, MD

Role: PRINCIPAL_INVESTIGATOR

Centro Medico Teknon

Locations

Centro Medico Teknon

Barcelona, , Spain

Countries

Spain

Other Identifiers

TPR602

Identifier Type: -

Identifier Source: org_study_id