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

This study is currently recruiting participants.
Verified January 2014 by USGI Medical
Sponsor:
Information provided by (Responsible Party):
USGI Medical
ClinicalTrials.gov Identifier:
NCT01843231
First received: April 22, 2013
Last updated: January 30, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Obesity
Device: g-CathTM EZ Suture Anchor Delivery Catheter
Other: Diet and Exercise Control Group

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study

Resource links provided by NLM:


Further study details as provided by USGI Medical:

Primary Outcome Measures:
  • Primary Safety Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Incidence and severity of Adverse Events [AE] over 12 Months

  • Primary Efficacy Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean % TBWL at 12 months for Treatment subjects compared to Control subjects

  • Co-Primary Efficacy Endpoint [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    The proportion of Treatment subjects achieving ≥ 5% TBWL at 12 months


Secondary Outcome Measures:
  • First Secondary Efficacy Endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Mean % TBWL at 24 months.

  • Second Secondary Efficacy endpoint [ Time Frame: 24 months ] [ Designated as safety issue: No ]
    Proportion of subjects achieving ≥ 5% TBWL at 24 months

  • Third Secondary Efficacy endpoint [ Time Frame: 2, 6, 12 months ] [ Designated as safety issue: No ]
    Satiety changes (volume and time to satiety at 2, 6, 12 months post-procedure)

  • Fourth Secondary Efficacy endpoint [ Time Frame: 12 & 18 months ] [ Designated as safety issue: No ]
    % Estimated Weight Loss [EWL] at 12 months and 18 months [% EWL will be calculated using BMI-25 criteria]


Estimated Enrollment: 40
Study Start Date: September 2013
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: g-Cath EZ Treatment Group
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
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
Active Comparator: Diet and exercise Control Group
Diet and Exercise only 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

Detailed 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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01843231

Contacts
Contact: James J White, D.O. 215-962-6178 jwhite@usgimedical.com

Locations
Austria
Krakenhaus Hallein Recruiting
Hallein, Salzburg, Austria
Contact: Karl Miller, MD, FACS    +43 6245 799-360    karl.miller@kh-hallein.at   
Principal Investigator: Karl Miller, MD, FACS         
Netherlands
Atrium Medical Centre Not yet recruiting
Heerlen, Netherlands
Contact: J.W. M Greve, MD, PhD    +31 45 576 65 99    j.greve@atriummc.nl   
Principal Investigator: J.W. M Greve, MD, PhD         
Spain
Centro Medico Teknon Recruiting
Barcelona, Spain
Contact: Jorge C. Espinos, Dr.         
Principal Investigator: Jorge C. Espinos, Dr.         
Sponsors and Collaborators
USGI Medical
Investigators
Principal Investigator: Jorge C. Espinos, Dr. Centro Medico Teknon
  More Information

No publications provided

Responsible Party: USGI Medical
ClinicalTrials.gov Identifier: NCT01843231     History of Changes
Other Study ID Numbers: 41936
Study First Received: April 22, 2013
Last Updated: January 30, 2014
Health Authority: Salzburg, Austria: Ethikkommission for the Bundesland Salzburg

Keywords provided by USGI Medical:
g-Cath EZ Suture Anchor Delivery Catheter
Weight Loss Intervention

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014