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LAP-BAND AP Early Experience Trial (APEX)
This study is currently recruiting participants.
Verified by Allergan Medical, December 2008
Sponsored by: Allergan Medical
Information provided by: Allergan Medical
ClinicalTrials.gov Identifier: NCT00501085
  Purpose

The primary objective of this study is to evaluate the LAP-BAND AP System in severely obese patients.


Condition
Obesity, Morbid

MedlinePlus related topics: Obesity
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective

Further study details as provided by Allergan Medical:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 500
Study Start Date: June 2007
Estimated Study Completion Date: September 2013
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Community sample

Criteria

Inclusion Criteria:

  • Patient is scheduled to receive the LAP-BAND AP System
  • Willingness to follow protocol requirements including ICF, HIPAA forms, follow-up schedule, complete patient questionnaires

Exclusion Criteria:

  • Per the LAP-BAND AP System DFU
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00501085

Contacts
Contact: Allergan Medical lapband_ap@allergan.com

Locations
United States, California
Allergan Medical Recruiting
Los Angeles, California, United States
Contact: Allergan Medical         lapband_ap@allergan.com    
Sponsors and Collaborators
Allergan Medical
Investigators
Study Director: Allergan Medical Allergan Medical
  More Information

Responsible Party: Allergan ( Allergan Medical )
Study ID Numbers: MedAff-LBAP201
Study First Received: July 11, 2007
Last Updated: December 8, 2008
ClinicalTrials.gov Identifier: NCT00501085  
Health Authority: United States: Institutional Review Board

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 14, 2009