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NCT00543140 · ClinicalTrials.gov registry record · Phase 4
Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band
A Phase 4 study, sponsored by Ethicon Endo-Surgery.
- Completed
- Registry status
- Phase 4
- Development phase
- 303
- Enrollment target
NCT00543140 is a Phase 4 study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 303 participants.
The verdict
NCT00543140, a Phase 4 study, has completed, sponsored by Ethicon Endo-Surgery.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 303 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related event {SADE}) of gastric banding at 4 and 5 year post implant.
Interventions
- DEVICE REALIZE™ Swedish Adjustable Gastric Band
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 303 participants |
| Start Date | 2006-08 |
| Est. Completion | 2015-01 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00543140
The ClinicalTrials.gov registry entry for NCT00543140 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 303 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ethicon Endo-Surgery, which has 39 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which REALIZE™ Swedish Adjustable Gastric Band is the first listed.
NCT00543140 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00543140 about?
NCT00543140 is a clinical study titled "Post Implantation/Post Market Evaluation of the Swedish Adjustable Gastric Band". The purpose of the study is to evaluate the long term safety of the Swedish Adjustable Gastric Band (SAGB) in subjects with an SAGB in place. Specifically it is designed to determine the re-operation rate (band revision, band replacement and explants resulting from serious adverse device-related eve...
What is the current status of trial NCT00543140?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 303 participants. The study started on 2006-08. Estimated completion is 2015-01.
What interventions are being tested in trial NCT00543140?
The interventions under investigation include: REALIZE™ Swedish Adjustable Gastric Band (DEVICE).
Who is sponsoring clinical trial NCT00543140?
This trial is sponsored by Ethicon Endo-Surgery, which has 39 total clinical trials registered on ClinicalTrials.gov.
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