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NCT02356614 · ClinicalTrials.gov registry record
A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study
A clinical trial, sponsored by Apollo Endosurgery.
- Terminated
- Registry status
- 325
- Enrollment target
NCT02356614: Clinical Trial study, sponsored by Apollo Endosurgery.
NCT02356614 is a clinical trial that was terminated before completion, run by Apollo Endosurgery. The registered enrollment target is 325 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02356614 was terminated before completion, sponsored by Apollo Endosurgery.
- TERMINATED
- Registry status
- 325 participants
- Enrollment target
Study Summary
This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and \< 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantation. The reason your study has been terminated is based on the availability of long-term safety and effectiveness data from the OSB Lead-HERo-002 study and published literature.
Primary Outcome
The primary objective is to assess the percentage of patients who experience an explant of the LAP BAND System within 5 years of implantation.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 325 participants |
| Start Date | 2015-03 |
| Est. Completion | 2018-03-08 |
Why NCT02356614 stopped before completion
NCT02356614 is an observational study that tracks outcomes without assigning an intervention. The registered 325 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT02356614 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02356614 about?
NCT02356614 is a clinical study titled "A Post-approval LAP-BAND® Lower Body Mass Index (LBMI) Study". This is a post-approval, multicenter, prospective, non-randomized, open-label, clinical study to evaluate the safety and effectiveness of the LAP-BAND® AP System in a lower obese population (BMI ≥ 30 kg/m2 and \< 40 kg/m2) with one or more obesity-related comorbidity up to 10 years after implantatio...
What is the current status of trial NCT02356614?
This trial is currently terminated. The enrollment target is 325 participants. The study started on 2015-03. Estimated completion is 2018-03-08.
Who is sponsoring clinical trial NCT02356614?
This trial is sponsored by Apollo Endosurgery, which has 7 total clinical trials registered on ClinicalTrials.gov.
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