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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: Completed Phase 4 study, sponsored by Ethicon Endo-Surgery.
NCT00543140 is a Phase 4 study that has completed, run by Ethicon Endo-Surgery. The registered enrollment target is 303 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
A reoperation was identified by satisfying all of the following criteria: * Is an SAE or is the action taken as the result of an SAE; * Is related to the device (i.e., has a relationship to study device that is indicated as Definite, Probable, Possible, or Unknown). In cases where the reoperation is the action taken for an SAE, then the SAE itself should be related to the device; * Is an explant, band revision, or band replacement resulting from a medical condition (perceived failure of weight
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 |
What the finished NCT00543140 record still lists
NCT00543140 is an interventional study that assigns participants to a tested intervention. The registered 303 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (42% lower).
The record links to 0 conditions, and to 1 intervention - of which REALIZE™ Swedish Adjustable Gastric Band is the first listed.
NCT00543140 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00543140's enrollment target sits among peer trials
303 266th of 2000 higher than 1,735 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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