Clinical trial NCT01448785: Abiliti™ Treatment in Obese Subjects
Official title: Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obesity
Morbid Obesity
Keywords: obesity
gastric stimulation
morbid obesity
Lead sponsor: IntraPace, Inc
Sponsor class: INDUSTRY
First posted: 2011-10-07
Enrollment: 165
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this post-market surveillance study is to compare the subject's weight loss and quality of life, and device safety performance of the abiliti System and the adjustable gastric banding therapies in obese to morbidly obese subjects.

Detailed description: This study is intended to provide additional data regarding the performance and safety of the abiliti system in comparison to gastric banding. The composite end-point of the study is designed to provide a direct comparison of the effectiveness of the devices for the treatment of obesity while giving consideration to the safety profile for each device and their impact on patient quality of life.

Eligibility criteria: Inclusion Criteria:

* Age of 18 - 60 years old at time of screening
* BMI of 40 to 55 or 35 to 39 with an obesity related comorbid condition at time of screening
* History of obesity ≥5 years
* The subject has been under routine care of the investigator or another single physician that can supply a medical record for at least 6 months prior to enrollment
* Women with childbearing potential (i.e., not post-menopausal or surgically sterilized) must agree to use adequate birth control methods
* No significant weight loss (\<5%) within four months prior to enrollment as documented in the subject's medical record.
* Successful psychological evaluation following the institution psychological evaluation protocol for bariatric surgery or successful historic assessment performed no more than 6 months prior to enrollment.
* Glycosylated Hemoglobin; HbA1c ≤ 7.0 % at Visit 2 or historic value performed no more than 3 months prior to enrollment.
* If taking anti-depressant medications, they must be stable for at least six months prior to enrollment
* Willingness to refrain from using prescription, over the counter or herbal weight loss products for the duration of the trial
* Alert, mentally competent, and able to understand and willing to comply with the requirements of the clinical trial, and personally motivated to abide by the requirements and restrictions of the clinical trial
* Able to provide voluntary informed consent

Exclusion Criteria:

* Any prior bariatric surgery
* Other implanted electrical stimulation devices (e.g. pacemaker, defibrillator, neurostimulator)
* Diagnosed with past or current psychiatric condition that may impair his/her ability to comply with the study procedures
* Use of anti-psychotic medications
* Diagnosed with a eating disorder such as bulimia or binge eating
* Obesity due to an endocrinopathy (e.g. Cushing disease)
* Insulin therapy
* GI disease such as hiatal hernia (\>5cm), gastroparesis, esophageal motility disorders or intractable constipation.
* Cirrhosis, chronic pancreatitis
* History of intestinal obstruction or adhesive peritonitis
* Any history of peptic ulcer disease within 5 years prior to enrollment
* Women who are pregnant, lactating or anticipate becoming pregnant within 24 months
* Arthritis or other pathologies limiting physical activities that physician feels should exclude the patient from the study.
* Chronic use of aspirin and/or non steroidal anti-inflammatory medications and unwillingness to discontinue use
* Cardiac history that physician feels should exclude the patient from the study.
* Concurrent use of weight loss medications.
* Use of another investigational device or agent in the 30 days prior to enrollment
* A history of life-threatening disease within 5 years prior to enrollment
* Any other condition that, in the opinion of the investigator, would make the subject unsuitable for the study

Primary outcomes:
measure: Non-inferiority of the abiliti therapy compared to adjustable gastric banding
timeFrame: 12 months
measure: Percentage of Responders
timeFrame: 12 months
measure: Safety
timeFrame: 12 months
Secondary outcomes:
measure: Safety
timeFrame: 6 and 12 months
measure: Quality of Life
timeFrame: 6 and 12 months
measure: Eating Behavior
timeFrame: 6 and 12 months
measure: Co-morbid Conditions
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: RILLIEUX Cedex
country: France
facility: Polyclinique de Rillieux, Clinique Lyon-Nord
city: Berlin
country: Germany
facility: MIC Ev. Krankenhaus Hubertus
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera
city: Graefelfing
country: Germany
facility: Wolfart Klinik
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Schwabach
country: Germany
facility: Stadtkrankenhaus Schwabach
city: Pisa
country: Italy
facility: Azienda Ospedaliera- University
city: Turin
country: Italy
facility: Clinica San Luca Torino
city: Vicenza
country: Italy
facility: Vicenza Regional Hospital
city: Madrid
country: Spain
facility: Complutense University of Madrid Hospital Clinico "San Carlos"
city: Sevilla
country: Spain
facility: Hospital Virgen del Roció
city: Winterthur
country: Switzerland
facility: Klinik Lindberg
city: Hampshire
country: United Kingdom
facility: Spire Southampton Hospital
state: Southampton
city: North Cheam
country: United Kingdom
facility: St. Anthony's Hospital
state: Surrey
city: Dewsbury
country: United Kingdom
facility: Mid Yorkshire NHS Trust
state: West Yorkshire
Study officials:
affiliation: Stadtkrankenhaus Schwabach
name: Thomas Horbach, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: St Anthony's Hospital, Surrey, England
name: Alberic Fiennes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Morales-Conde S, Alarcon Del Agua I, Busetto L, Favretti F, Anselmino M, Rovera GM, Socas-Macias M, Barranco-Moreno A, Province-Azalde R, Torres AJ. Implanted Closed-Loop Gastric Electrical Stimulation (CLGES) System with Sensor-Based Feedback Safely Limits Weight Regain at 24 Months. Obes Surg. 2018 Jun;28(6):1766-1774. doi: 10.1007/s11695-017-3093-8.
citation: Busetto L, Torres AJ, Morales-Conde S, Alarcon Del Agua I, Moretto C, Fierabracci P, Rovera G, Segato G, Rubio MA, Favretti F. Impact of the feedback provided by a gastric electrical stimulation system on eating behavior and physical activity levels. Obesity (Silver Spring). 2017 Mar;25(3):514-521. doi: 10.1002/oby.21760. Epub 2017 Feb 6.
citation: Alarcon Del Agua I, Socas-Macias M, Busetto L, Torres-Garcia A, Barranco-Moreno A, Garcia de Luna PP, Morales-Conde S. Post-implant Analysis of Epidemiologic and Eating Behavior Data Related to Weight Loss Effectiveness in Obese Patients Treated with Gastric Electrical Stimulation. Obes Surg. 2017 Jun;27(6):1573-1580. doi: 10.1007/s11695-016-2495-3.