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
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: 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 July 22, 2014