NCT01448785

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.

Trial Health

50
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
165

participants targeted

Target at P75+ for not_applicable obesity

Timeline
Completed

Started Apr 2011

Typical duration for not_applicable obesity

Geographic Reach
6 countries

15 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 7, 2011

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

October 31, 2011

Status Verified

October 1, 2011

Enrollment Period

1.8 years

First QC Date

October 3, 2011

Last Update Submit

October 27, 2011

Conditions

ObesityMorbid Obesity

Keywords

obesitygastric stimulationmorbid obesity

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (4)

  • Safety

    6 and 12 months

  • Quality of Life

    6 and 12 months

  • Eating Behavior

    6 and 12 months

  • Co-morbid Conditions

    6 and 12 months

Study Arms (2)

abiliti Group

ACTIVE COMPARATOR

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

Gastric Band Group

ACTIVE COMPARATOR

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)

Interventions

abiliti system implantDEVICE

Subjects will receive implanted abiliti System.

Also known as: abiliti
abiliti Group
Laparoscopic adjustable gastric band (Allergan Lap Band)DEVICE

Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.

Also known as: gastric band
Gastric Band Group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Polyclinique de Rillieux, Clinique Lyon-Nord

Rillieux Cedex, 69165, France

RECRUITING

MIC Ev. Krankenhaus Hubertus

Berlin, 14129, Germany

RECRUITING

SRH Wald-Klinikum Gera

Gera, 07548, Germany

RECRUITING

Wolfart Klinik

Gräfelfing, 92166, Germany

ACTIVE NOT RECRUITING

Universitätsklinikum Hamburg-Eppendorf

Hamburg, 20246, Germany

RECRUITING

Stadtkrankenhaus Schwabach

Schwabach, 91126, Germany

RECRUITING

Azienda Ospedaliera- University

Pisa, Italy

NOT YET RECRUITING

Clinica San Luca Torino

Turin, Italy

NOT YET RECRUITING

Vicenza Regional Hospital

Vicenza, 36100, Italy

NOT YET RECRUITING

Complutense University of Madrid Hospital Clinico "San Carlos"

Madrid, 28290, Spain

NOT YET RECRUITING

Hospital Virgen del Roció

Seville, 41013, Spain

RECRUITING

Klinik Lindberg

Winterthur, 8400, Switzerland

RECRUITING

Spire Southampton Hospital

Hampshire, Southampton, SO16 6UY, United Kingdom

NOT YET RECRUITING

St. Anthony's Hospital

North Cheam, Surrey, SM3 9DW, United Kingdom

NOT YET RECRUITING

Mid Yorkshire NHS Trust

Dewsbury, West Yorkshire, WF13 4HS, United Kingdom

NOT YET RECRUITING

Related Publications (3)

  • 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.

    PMID: 29333595DERIVED

  • 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.

    PMID: 28164463DERIVED

  • 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.

    PMID: 28013450DERIVED

MeSH Terms

Conditions

ObesityObesity, Morbid

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Thomas Horbach, MD

    Stadtkrankenhaus Schwabach

    PRINCIPAL INVESTIGATOR

  • Alberic Fiennes, MD

    St Anthony's Hospital, Surrey, England

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Nardelli

CONTACT

650-316-4065

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 3, 2011

First Posted

October 7, 2011

Study Start

April 1, 2011

Primary Completion

January 1, 2013

Study Completion

January 1, 2015

Last Updated

October 31, 2011

Record last verified: 2011-10

Locations

IT(3)GB(3)CH(1)DE(5)ES(2)FR(1)