Clinical trial NCT01843231: Use of the Incisionless Operating Platform as a Primary Treatment for Obesity vs. Diet-Exercise Alone
Official title: A Randomized Controlled Multicenter Feasibility Study of an IncisionLEss Operating Platform for Primary ObeSiTy vs. Diet-exercise Alone: The MILEPOST Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Keywords: g-Cath EZ Suture Anchor Delivery Catheter
Weight Loss Intervention
Lead sponsor: USGI Medical
Sponsor class: INDUSTRY
First posted: 2013-04-30
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Primary Safety Endpoint
timeFrame: 12 months
measure: Primary Efficacy Endpoint
timeFrame: 12 months
measure: Co-Primary Efficacy Endpoint
timeFrame: 12 months
Secondary outcomes:
measure: First Secondary Efficacy Endpoint
timeFrame: 24 months
measure: Second Secondary Efficacy endpoint
timeFrame: 24 months
measure: Third Secondary Efficacy endpoint
timeFrame: 2, 6, 12 months
measure: Fourth Secondary Efficacy endpoint
timeFrame: 12 & 18 months
Other outcomes:
Locations:
city: Hallein
country: Austria
facility: Krakenhaus Hallein
state: Salzburg
city: Heerlen
country: Netherlands
facility: Atrium Medical Centre
city: Barcelona
country: Spain
facility: Centro Medico Teknon
Study officials:
affiliation: Centro Medico Teknon
name: Jorge C. Espinos, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.