Abiliti™ Treatment in Obese Subjects

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01448785
• Other study ID #: CS-007-P
• Status: Recruiting
• Phase: N/A
• First received: October 3, 2011
• Last updated: October 27, 2011
• Start date: April 2011
• Est. completion date: January 2015

Study information

• Verified date: October 2011
• Source: IntraPace, Inc
• Contact: Robert Nardelli
• Phone: 650-316-4065
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: National Health ServiceItaly: Ministry of HealthSpain: Spanish Agency of MedicinesSwitzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 165
• Est. completion date: January 2015
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Device:
• abiliti system implant
Subjects will receive implanted abiliti System.
• Laparoscopic adjustable gastric band (Allergan Lap Band)
Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.

Locations

Country	Name	City	State
France	Polyclinique de Rillieux, Clinique Lyon-Nord	RILLIEUX Cedex
Germany	MIC Ev. Krankenhaus Hubertus	Berlin
Germany	SRH Wald-Klinikum Gera	Gera
Germany	Wolfart Klinik	Graefelfing
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Stadtkrankenhaus Schwabach	Schwabach
Italy	Azienda Ospedaliera- University	Pisa
Italy	Clinica San Luca Torino	Turin
Italy	Vicenza Regional Hospital	Vicenza
Spain	Complutense University of Madrid Hospital Clinico "San Carlos"	Madrid
Spain	Hospital Virgen del Roció	Sevilla
Switzerland	Klinik Lindberg	Winterthur
United Kingdom	Mid Yorkshire NHS Trust	Dewsbury	West Yorkshire
United Kingdom	Spire Southampton Hospital	Hampshire	Southampton
United Kingdom	St. Anthony's Hospital	North Cheam	Surrey

Sponsors (1)

Lead Sponsor	Collaborator
IntraPace, Inc

Countries where clinical trial is conducted

France,  Germany,  Italy,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	Percentage of Responders	Fifty (50 %) of the subject population must obtain an EWL = 25%	12 months	No
Primary	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	Yes
Secondary	Safety	Frequency of device and procedure-related adverse events	6 and 12 months	Yes
Secondary	Quality of Life	Change in the quality of life using the IWQOL-Lite questionnaire	6 and 12 months	No
Secondary	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	No
Secondary	Co-morbid Conditions	Evaluation of the changes in blood pressure, lipid panel, HbA1c	6 and 12 months	No