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Abiliti™ Treatment in Obese Subjects

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2011 by IntraPace, Inc.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
IntraPace, Inc
ClinicalTrials.gov Identifier:
NCT01448785
First received: October 3, 2011
Last updated: October 27, 2011
Last verified: October 2011
  Purpose
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.

Condition Intervention
Obesity
Morbid Obesity
Device: abiliti system implant
Device: Laparoscopic adjustable gastric band (Allergan Lap Band)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Abiliti™ Treatment in Obese Subjects: A Randomized Post-Market Surveillance Multicenter Study

Further study details as provided by IntraPace, Inc:

Primary Outcome Measures:
  • Non-inferiority of the abiliti therapy compared to adjustable gastric banding [ Time Frame: 12 months ] [ Designated as safety issue: No ]

    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)

  • Percentage of Responders [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Fifty (50 %) of the subject population must obtain an EWL ≥ 25%

  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    • 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;


Secondary Outcome Measures:
  • Safety [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
    Frequency of device and procedure-related adverse events

  • Quality of Life [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Change in the quality of life using the IWQOL-Lite questionnaire

  • Eating Behavior [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Change in the eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) using the Three Factor Eating Questionnaire (TFEQ).

  • Co-morbid Conditions [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
    Evaluation of the changes in blood pressure, lipid panel, HbA1c


Estimated Enrollment: 165
Study Start Date: April 2011
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: gastric 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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  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: NCT01448785

Locations
France
Polyclinique de Rillieux, Clinique Lyon-Nord
RILLIEUX Cedex, France, 69165
Germany
MIC Ev. Krankenhaus Hubertus
Berlin, Germany, 14129
SRH Wald-Klinikum Gera
Gera, Germany, 07548
Wolfart Klinik
Graefelfing, Germany, 92166
Universitätsklinikum Hamburg-Eppendorf
Hamburg, Germany, 20246
Stadtkrankenhaus Schwabach
Schwabach, Germany, 91126
Italy
Azienda Ospedaliera- University
Pisa, Italy
Clinica San Luca Torino
Turin, Italy
Vicenza Regional Hospital
Vicenza, Italy, 36100
Spain
Complutense University of Madrid Hospital Clinico "San Carlos"
Madrid, Spain, 28290
Hospital Virgen del Roció
Sevilla, Spain, 41013
Switzerland
Klinik Lindberg
Winterthur, Switzerland, 8400
United Kingdom
Spire Southampton Hospital
Hampshire, Southampton, United Kingdom, SO16 6UY
St. Anthony's Hospital
North Cheam, Surrey, United Kingdom, SM3 9DW
Mid Yorkshire NHS Trust
Dewsbury, West Yorkshire, United Kingdom, WF13 4HS
Sponsors and Collaborators
IntraPace, Inc
Investigators
Principal Investigator: Thomas Horbach, MD Stadtkrankenhaus Schwabach
Principal Investigator: Alberic Fiennes, MD St Anthony's Hospital, Surrey, England
  More Information

Responsible Party: IntraPace, Inc
ClinicalTrials.gov Identifier: NCT01448785     History of Changes
Other Study ID Numbers: CS-007-P 
Study First Received: October 3, 2011
Last Updated: October 27, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: National Health Service
Italy: Ministry of Health
Spain: Spanish Agency of Medicines
Switzerland: Swissmedic

Keywords provided by IntraPace, Inc:
obesity
gastric stimulation
morbid obesity

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on December 02, 2016