Abiliti™ Treatment in Obese Subjects

Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study

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.

Study Overview

• Status: Unknown
• Conditions: Obesity; Morbid Obesity
• Intervention / Treatment: Device: abiliti system implant; Device: Laparoscopic adjustable gastric band (Allergan Lap Band)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 165
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Robert Nardelli; Phone Number: 650-316-4065

Study Locations

• France
  • RILLIEUX Cedex, France, 69165
    • Recruiting
    • Polyclinique de Rillieux, Clinique Lyon-Nord
    • Contact: Jerome Dargent, MD
    • Principal Investigator: Jerome Dargent, MD
• Germany
  • Berlin, Germany, 14129
    • Recruiting
    • MIC Ev. Krankenhaus Hubertus
    • Contact: Martin Susewind, MD
    • Principal Investigator: Martin Susewind, MD
  • Gera, Germany, 07548
    • Recruiting
    • SRH Wald-Klinikum Gera
    • Contact: Christine Stroh, MD
    • Principal Investigator: Christine Stroh, MD
  • Graefelfing, Germany, 92166
    • Active, not recruiting
    • Wolfart Klinik
  • Hamburg, Germany, 20246
    • Recruiting
    • Universitätsklinikum Hamburg-Eppendorf
    • Principal Investigator: Oliver Mann, MD
  • Schwabach, Germany, 91126
    • Recruiting
    • Stadtkrankenhaus Schwabach
    • Principal Investigator: Thomas Horbach, MD
• Italy
  • Pisa, Italy
    • Not yet recruiting
    • Azienda Ospedaliera- University
    • Contact: Marco Anselmino, MD
    • Principal Investigator: Marco Anselmino, MD
  • Turin, Italy
    • Not yet recruiting
    • Clinica San Luca Torino
    • Contact: Giuseppe M Rovera, MD
    • Principal Investigator: Giuseppe M Rovera, MD
  • Vicenza, Italy, 36100
    • Not yet recruiting
    • Vicenza Regional Hospital
    • Contact: Franco Favretti, MD
    • Principal Investigator: Franco Favretti, MD
• Spain
  • Madrid, Spain, 28290
    • Not yet recruiting
    • Complutense University of Madrid Hospital Clinico "San Carlos"
    • Contact: Antonio J Torres, MD
    • Principal Investigator: Antonio J Torres, MD
  • Sevilla, Spain, 41013
    • Recruiting
    • Hospital Virgen del Rocío
    • Contact: Salvador Morales Conde, MD
    • Principal Investigator: Salvador Morales Conde, MD
• Switzerland
  • Winterthur, Switzerland, 8400
    • Recruiting
    • Klinik Lindberg
    • Contact: Fritz Horber, MD
    • Principal Investigator: Fritz Horber, MD
• United Kingdom
  • Southampton
    • Hampshire, Southampton, United Kingdom, SO16 6UY
      • Not yet recruiting
      • Spire Southampton Hospital
      • Contact: James Byrne, MD
      • Principal Investigator: James Byrne, MD
  • Surrey
    • North Cheam, Surrey, United Kingdom, SM3 9DW
      • Not yet recruiting
      • St. Anthony's Hospital
      • Contact: Alberic Fiennes, MD
      • Principal Investigator: Alberic Fiennes, MD
  • West Yorkshire
    • Dewsbury, West Yorkshire, United Kingdom, WF13 4HS
      • Not yet recruiting
      • Mid Yorkshire NHS Trust
      • Contact: Chinnadorai Rajeswaran, MD
      • Principal Investigator: Chinnadorai Rajeswaran, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: abiliti Group; Subjects will receive implanted abiliti System. The device will be activated to deliver therapy at implant. Gastric stimulation performance testing, therapy adjustment and dietary/exercise counseling will be conducted at each visit.	Device: abiliti system implant; Subjects will receive implanted abiliti System.; Other Names: abiliti
ACTIVE_COMPARATOR: Gastric Band Group; Subjects will receive an implanted laparoscopic adjustable gastric band. The subjects will have their band adjusted following the standard of care. Dietary/exercise counseling will be conducted at each visit.	Device: Laparoscopic adjustable gastric band (Allergan Lap Band); Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.; Other Names: gastric band

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Non-inferiority of the abiliti therapy compared to adjustable gastric banding	The non-inferiority of the abiliti therapy compared to adjustable gastric banding will be measured using a composite endpoint at the end of the study period. The success criteria will be the percentage of subjects in each group who meet all of the following criteria: Achieve at least 20% excess weight loss (%EWL) from implant to end of the study period.; Experience no serious or severe adverse events related to the device or the procedure; No significant negative change in quality of life using the Impact Of Weight On Quality Of Life-Lite Questionnaire (IWQOL-Lite)	12 months
Percentage of Responders	Fifty (50 %) of the subject population must obtain an EWL ≥ 25%	12 months
Safety	Incidence and seriousness of all adverse events.; Incidence of device or procedure-related adverse events; Frequency of clinically significant abnormal laboratory values as determined by the Investigator;	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety	Frequency of device and procedure-related adverse events	6 and 12 months
Quality of Life	Change in the quality of life using the IWQOL-Lite questionnaire	6 and 12 months
Eating Behavior	Change in the eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ).	6 and 12 months
Co-morbid Conditions	Evaluation of the changes in blood pressure, lipid panel, HbA1c	6 and 12 months

Collaborators and Investigators

• Sponsor: IntraPace, Inc
• Investigators: Principal Investigator: Thomas Horbach, MD, Stadtkrankenhaus Schwabach; Principal Investigator: Alberic Fiennes, MD, St Anthony's Hospital, Surrey, England

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2011
• Primary Completion (ANTICIPATED): January 1, 2013
• Study Completion (ANTICIPATED): January 1, 2015

Study Registration Dates

• First Submitted: October 3, 2011
• First Submitted That Met QC Criteria: October 5, 2011
• First Posted (ESTIMATE): October 7, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2011
• Last Update Submitted That Met QC Criteria: October 27, 2011
• Last Verified: October 1, 2011

More Information

Terms related to this study

• Keywords: obesity; morbid obesity; gastric stimulation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: CS-007-P