LAP-BAND AP Early Experience Trial (APEX)
This study is ongoing, but not recruiting participants.
Sponsor:
Allergan Medical
Information provided by (Responsible Party):
Allergan Medical
ClinicalTrials.gov Identifier:
NCT00501085
First received: July 11, 2007
Last updated: December 12, 2012
Last verified: December 2012
| Tracking Information | |||||
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| First Received Date ICMJE | July 11, 2007 | ||||
| Last Updated Date | December 12, 2012 | ||||
| Start Date ICMJE | June 2007 | ||||
| Primary Completion Date | Not Provided | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00501085 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | LAP-BAND AP Early Experience Trial (APEX) | ||||
| Official Title ICMJE | Not Provided | ||||
| Brief Summary | The primary objective of this study is to evaluate the LAP-BAND AP System in severely obese patients. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Community sample |
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| Condition ICMJE | Obesity, Morbid | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Shayani V, Voellinger D, Liu C, Cornell C, Okerson T. Safety and efficacy of the LAP-BAND AP® adjustable gastric band in the treatment of obesity: results at 2 years. Postgrad Med. 2012 Jul;124(4):181-8. doi: 10.3810/pgm.2012.07.2561. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 500 | ||||
| Estimated Completion Date | March 2014 | ||||
| Primary Completion Date | Not Provided | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00501085 | ||||
| Other Study ID Numbers ICMJE | MedAff-LBAP201 | ||||
| Has Data Monitoring Committee | Not Provided | ||||
| Responsible Party | Allergan Medical | ||||
| Study Sponsor ICMJE | Allergan Medical | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Allergan Medical | ||||
| Verification Date | December 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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