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Abiliti™ Treatment in Obese Subjects

NCT01448785 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 165

Last updated 2011-10-31

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

abiliti system implant

Subjects will receive implanted abiliti System.

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.

Sponsors & Collaborators

  • IntraPace, Inc

    lead INDUSTRY

Principal Investigators

  • Thomas Horbach, MD · Stadtkrankenhaus Schwabach

  • Alberic Fiennes, MD · St Anthony's Hospital, Surrey, England

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2013-01-31
Completion
2015-01-31

Countries

  • France
  • Germany
  • Italy
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01448785 on ClinicalTrials.gov