LAP-BAND Observational Cohort

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2006 by Inamed.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Inamed
ClinicalTrials.gov Identifier:
NCT00283972
First received: January 24, 2006
Last updated: January 30, 2006
Last verified: January 2006
  Purpose

To prospectively observe the association of the LAP-BAND procedure on quality of life, anthropometric, metabolic and biochemical parameters in morbidly obese patients when performed by experienced US surgeons. The study will also include a complete economic analysis of the LAP-BAND procedure and follow-up costs Hypothesis: Measurements defining quality of life and the severity of obesity and obesity related comorbidities improve significantly over baseline with the LAP-BAND System treatment at 6 and 12 months post surgery when performed by an experienced surgeon.


Condition Intervention Phase
Epworth Sleepiness Scale
Glycemic Control
Liver Function
Inflammation
Iron and Bone Turnover
SF-36
IW-QOL Lite HRQoL
Device: LAP-BAND System
Phase 4

Study Type: Observational
Study Design: Observational Model: Defined Population
Time Perspective: Longitudinal
Official Title: Health Outcome Study of LAP-BAND Adjustable Gastric Banding System

Resource links provided by NLM:


Further study details as provided by Inamed:

Estimated Enrollment: 240
Study Start Date: June 2005
Estimated Study Completion Date: December 2006
Detailed Description:

Study Type: Observational cohort. Single arm (non-comparative), non-randomized, multi-site surgical case series.

Objective: To prospectively observe the association of the LAP-BAND System device on measurements of quality of life, anthropometric, metabolic and biochemical parameters in morbidly obese patients when performed by experienced U.S. surgeons. Cost effectiveness analysis will also be done.

Numbers: This study will enroll 240 patients total from six U.S. bariatric surgical practices

Duration: Individual subject participation will be approximately 15 months. Data will be collected at a baseline less than three months prior to surgery or before starting a Very Low Calorie Diet (VLCD), then at 6 and 12 months post surgery. The total duration, including enrollment, of the observational period for the cohort is expected to be 21 months. Subjects have the option to consent for future contact by investigators for a period of 10 years following their surgery.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Morbid Obesity: BMI >40 kg/m2 or
  • BMI > or equal to 35 kg/m2 with significant obesity related comorbidity
  • Age 18 years old or older
  • Dietary attempts at weight control have been ineffective
  • Consented for surgery with LAP-BAND System by pre qualified bariatric surgeon
  • Willingness and ability to follow protocol requirements
  • Residing within a reasonable distance from the surgeon's office and being able to travel to the surgeon's office to complete all routine follow-up visits

Exclusion Criteria:

  • Previous bariatric surgery
  • Psychological impairments that would impede compliance with study follow up schedule, as determined by attending surgeons
  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: NCT00283972

Sponsors and Collaborators
Inamed
Investigators
Study Chair: Daniel Deykin, MD Massachusetts Veterans Epidemiology Research adn Information Center
Principal Investigator: Louis Fiore, MD Department of Veterans Affairs
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00283972     History of Changes
Other Study ID Numbers: 12242004P
Study First Received: January 24, 2006
Last Updated: January 30, 2006
Health Authority: United States: Office for Human Resource Protections (OHRP)
United States: Registration # IRB00000755

Keywords provided by Inamed:
Health Outcome Study

Additional relevant MeSH terms:
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on August 28, 2014