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

Obesity Clinical Trial

— MILEPOST  

Official title:

A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT01843231
• Other study ID #: 41936
• Status: Unknown status
• Phase: N/A
• First received: April 22, 2013
• Last updated: April 1, 2015
• Start date: September 2013
• Est. completion date: August 2016

Study information

• Verified date: April 2015
• Source: USGI Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This study will 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. The weight loss outcomes will be used to assess treatment effect. This study is a multi-center, open/unblinded, prospective randomized feasibility study (3:1Treatment: Control) study. Patients in the control group will be offered the opportunity to crossover to the treatment group at 12 months.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 40
• Est. completion date: August 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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,

Exclusion Criteria:

• 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

• Active gastric ulcer disease

• Gastric outlet obstruction or stenosis

• Beck Depression Inventory (Short) Score =12 (see Appendix IV);

• Subject has a history of drug or alcohol abuse or actively abusing either as defined by Cage and DAST [drug use] questionnaires or positive Urinalysis [UA] drug screen

• Severe disturbances in eating behavior (i.e. binge eating)

• Known presence of a significant depression, psychosis, or other mood or eating disorder

• Actively treated depression (except for stable treated depression for >1year and normal [Beck Depression Inventory [BDI] and psych exam)

• Present or past history of psychosis or other mood or eating disorder

• Non-ambulatory or has significant impairment of mobility

• Known hormonal or genetic cause for obesity with the exception of treated hypothyroidism.

• Participating in another clinical study

• Is a first degree relative of investigator, or support staff involved in the study.

• Employed by investigator or institution involved in the study

• Subject is not able to provide written informed consent

Related Conditions & MeSH terms

• Obesity

Intervention

Device:
• g-CathTM EZ Suture Anchor Delivery Catheter
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

Other:
• Diet and Exercise Control Group
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

Locations

Country	Name	City	State
Austria	Krakenhaus Hallein	Hallein	Salzburg
Netherlands	Atrium Medical Centre	Heerlen
Spain	Centro Medico Teknon	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
USGI Medical

Countries where clinical trial is conducted

Austria,  Netherlands,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary Safety Endpoint	Incidence and severity of Adverse Events [AE] over 12 Months	12 months
Primary	Primary Efficacy Endpoint	Mean % TBWL at 12 months for Treatment subjects compared to Control subjects	12 months
Primary	Co-Primary Efficacy Endpoint	The proportion of Treatment subjects achieving = 5% TBWL at 12 months	12 months
Secondary	First Secondary Efficacy Endpoint	Mean % TBWL at 24 months.	24 months
Secondary	Second Secondary Efficacy endpoint	Proportion of subjects achieving = 5% TBWL at 24 months	24 months
Secondary	Third Secondary Efficacy endpoint	Satiety changes (volume and time to satiety at 2, 6, 12 months post-procedure)	2, 6, 12 months
Secondary	Fourth Secondary Efficacy endpoint	% Estimated Weight Loss [EWL] at 12 months and 18 months [% EWL will be calculated using BMI-25 criteria]	12 & 18 months