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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 29, 2014