Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone

NCT01843231 | Unknown

• 1 other identifier: 41936
• Study Type: interventional
• Target: 40
• Locations: 3 countries
• Sites: 3

Brief Summary

This study is a multi-center, open/unblended study (3:1Treatment: Control) to evaluate the safety and effectiveness of the g-Cath EZ Suture Anchor Delivery Catheter as an early weight loss intervention compared to a diet and exercise control only. Mean % Total Body Weight Loss \[TBWL\] in Treatment subjects versus that of Control subjects at 12 months is the primary endpoint. The proportion of subjects achieving ≥ 5% TBWL at 12 months in the treatment group is a co-primary endpoint.

Conditions

Obesity

Keywords

g-Cath EZ Suture Anchor Delivery Catheter; Weight Loss Intervention

Outcome Measures

Primary Outcomes (3)

• Primary Safety Endpoint

  Incidence and severity of Adverse Events \[AE\] over 12 Months

  12 months

• Primary Efficacy Endpoint

  Mean % TBWL at 12 months for Treatment subjects compared to Control subjects

  12 months

• Co-Primary Efficacy Endpoint

  The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months

  12 months

Secondary Outcomes (4)

• First Secondary Efficacy Endpoint

  24 months

• Second Secondary Efficacy endpoint

  24 months

• Third Secondary Efficacy endpoint

  2, 6, 12 months

• Fourth Secondary Efficacy endpoint

  12 & 18 months

Study Arms (2)

g-Cath EZ Treatment Group

EXPERIMENTAL

Evaluate the safety and effectiveness of the g-CathTM EZ Suture Anchor Delivery Catheter as an early weight loss intervention

Device: g-CathTM EZ Suture Anchor Delivery Catheter

Diet and exercise Control Group

ACTIVE COMPARATOR

Diet and Exercise only control group

Other: Diet and Exercise Control Group

Interventions

g-CathTM EZ Suture Anchor Delivery Catheter DEVICE

Use of the g-Cath EZ Suture Anchor Delivery Catheter for the placement of g-cath EZ suture anchors as an early weight loss intervention + diet and exercise as compared to those in the diet and exercise control group

g-Cath EZ Treatment Group

Diet and Exercise Control Group OTHER

Patients in a diet and exercise only control group that will be compared to those in the g-Cath EZ Suture Anchor Delivery Catheter treatment group

Diet and exercise Control Group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Age 20-60 years
• Body Mass Index \[BMI\] of \>30 and \<40 with or without a co-morbid condition
• Subject has failed more conservative weight reduction alternatives such as supervised diet, exercise or behavior modification programs in the last year
• No significant weight change (+/- 5% of total body weight) in last 6 months
• American Society Anesthesiologists-Physical Status score ≤ 2 (Appendix III),
• Subject agrees not to have any additional weight loss interventional procedures or liposuction for at least 30 months following study enrollment,
• Has not taken any prescription or over the counter weight loss medications for at least 6 months,
• Signed informed consent.
• Subject is willing to cooperate with post-operative dietary recommendations and assessment tests,

You may not qualify if:

• History of (or intraoperative evidence of) bariatric, gastric or esophageal surgery
• Esophageal stricture or other anatomy and/or condition that could preclude passage of endolumenal instruments
• Severe gastroesophageal reflux disease (GERD), defined as symptoms that cause subject severe discomfort, compromise performance of daily activities, and/or condition is not entirely controlled with prescription drug therapy
• Known hiatal hernia \>3 centimeters by history or as determined by Upper Gastrointestinal exam or endoscopy
• Pancreatic insufficiency/disease
• Active peptic ulcer
• Pregnancy or plans of pregnancy in the next 12 months
• Present Corticosteroid Use
• History of inflammatory disease of Gastrointestinal \[GI\] tract; Coagulation disorders; hepatic insufficiency or cirrhosis
• History or present use of insulin or insulin derivatives for treatment of diabetes
• Type II Diabetes Mellitus \[DM\] (as defined by Glycosylated Hemoglobin \[HgbA1c\] \>6.5) for greater than 2 years at the time of enrollment
• Uncontrolled Type II DM (HgbA1c \> 7.0 at screening)
• Quit smoking within last 6 months at time of enrollment or plans to quit smoking in the next year
• Immunosuppression
• Portal hypertension and/or varices

Sponsors & Collaborators

• USGI Medical: lead

Study Sites (3)

Krakenhaus Hallein

Hallein, Salzburg, Austria

Location

Atrium Medical Centre

Heerlen, Netherlands

Location

Centro Medico Teknon

Barcelona, Spain

Location

Related Publications (1)

• Miller K, Turro R, Greve JW, Bakker CM, Buchwald JN, Espinos JC. MILEPOST Multicenter Randomized Controlled Trial: 12-Month Weight Loss and Satiety Outcomes After pose SM vs. Medical Therapy. Obes Surg. 2017 Feb;27(2):310-322. doi: 10.1007/s11695-016-2295-9.

  PMID: 27468907 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Diet

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Jorge C. Espinos, Dr.

  Centro Medico Teknon

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 22, 2013
• First Posted: April 30, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2016
• Last Updated: April 3, 2015

Record last verified: 2015-04

Locations

ES (1); AU (1); NL (1)