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

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

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Device: g-CathTM EZ Suture Anchor Delivery Catheter; Other: Diet and Exercise Control 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.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Salzburg
    • Hallein, Salzburg, Austria
      • Krakenhaus Hallein
• Netherlands
  • Heerlen, Netherlands
    • Atrium Medical Centre
• Spain
  • Barcelona, Spain
    • Centro Médico Teknon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
First Secondary Efficacy Endpoint	Mean % TBWL at 24 months.	24 months
Second Secondary Efficacy endpoint	Proportion of subjects achieving ≥ 5% TBWL at 24 months	24 months
Third Secondary Efficacy endpoint	Satiety changes (volume and time to satiety at 2, 6, 12 months post-procedure)	2, 6, 12 months
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

Collaborators and Investigators

• Sponsor: USGI Medical
• Investigators: Principal Investigator: Jorge C. Espinos, Dr., Centro Médico Teknon

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Anticipated): August 1, 2016

Study Registration Dates

• First Submitted: April 22, 2013
• First Submitted That Met QC Criteria: April 25, 2013
• First Posted (Estimate): April 30, 2013

Study Record Updates

• Last Update Posted (Estimate): April 3, 2015
• Last Update Submitted That Met QC Criteria: April 1, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: g-Cath EZ Suture Anchor Delivery Catheter; Weight Loss Intervention
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 41936