LAP-BAND AP Early Experience Trial (APEX)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00501085
First received: July 11, 2007
Last updated: June 14, 2013
Last verified: June 2013
  Purpose

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


Condition
Obesity, Morbid

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:


Further study details as provided by Allergan Medical:

Estimated Enrollment: 500
Study Start Date: June 2007
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
  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

Locations
United States, California
Allergan Medical
Los Angeles, California, United States
Sponsors and Collaborators
Allergan Medical
Investigators
Study Director: Allergan Medical Allergan Medical
  More Information

No publications provided by Allergan Medical

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Allergan Medical
ClinicalTrials.gov Identifier: NCT00501085     History of Changes
Other Study ID Numbers: MedAff-LBAP201
Study First Received: July 11, 2007
Last Updated: June 14, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on April 17, 2014