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LAP-BAND Observational Cohort

NCT00283972 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 240

Last updated 2006-01-31

No results posted yet for this study

Summary

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.

Conditions

  • Epworth Sleepiness Scale
  • Glycemic Control
  • Liver Function
  • Inflammation
  • Iron and Bone Turnover
  • SF-36
  • IW-QOL Lite HRQoL

Interventions

DEVICE

LAP-BAND System

Sponsors & Collaborators

  • Massachusetts Veterans Epidemiology Research and Information Center

    collaborator FED

  • Inamed

    lead INDUSTRY

Principal Investigators

  • Daniel Deykin, MD · Massachusetts Veterans Epidemiology Research adn Information Center

  • Louis Fiore, MD · Massachusetts Veterans Epidemiology Research and Information Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-06-30
Completion
2006-12-31

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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 NCT00283972 on ClinicalTrials.gov