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NCT02627794 · ClinicalTrials.gov registry record · Phase 3
Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery
A Phase 3 study, sponsored by Cedars-Sinai Medical Center.
- Terminated
- Registry status
- Phase 3
- Development phase
- 3
- Enrollment target
NCT02627794 is a Phase 3 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 3 participants.
The verdict
NCT02627794, a Phase 3 study, was terminated before completion, sponsored by Cedars-Sinai Medical Center.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 3 participants
- Enrollment target
Study Summary
Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic rhinosinusitis that is not adequately controlled with maximal medical therapy. In some patients, underlying inflammation (discharge, edema and polyposis), compounded by inflammation caused by surgical trauma may lead to an uncontrolled healing response, which results in the synechiae formation in the middle meatus (MM). Incidence of synechiae formation varies in literature and ranges between 4-35%. Presence of middle meatal synechiae can impair sinus drainage, promote sinusitis, and limit endoscopic visualization of the sinus cavities postoperatively. This may result in difficulty in performing postoperative routine endoscopic debridement and examination, which is paramount to a successful outcome from ESS. Spacers are often inserted during surgery between nasal mucosal surfaces to prevent synechiae. The aim of this study is to see if a steroid-impregnated spacer is more effective at reducing inflammation after sinus surgery than a Silastic spacer.
Interventions
- DEVICE Restora™ Steroid eluting spacer
- DEVICE Silastic Silicone Spacer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02627794
The ClinicalTrials.gov registry entry for NCT02627794 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cedars-Sinai Medical Center, which has 339 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Restora™ Steroid eluting spacer is the first listed.
NCT02627794 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02627794 about?
NCT02627794 is a clinical study titled "Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery". Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic rhinosinusitis that is not adequately controlled with maximal medical therapy. In some patients, underlying inflammation (discharge, edema and polyposis), compounded by inflammation caused by surgical trauma may l...
What is the current status of trial NCT02627794?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 3 participants. The study started on 2015-12. Estimated completion is 2016-04.
What interventions are being tested in trial NCT02627794?
The interventions under investigation include: Restora™ Steroid eluting spacer (DEVICE), Silastic Silicone Spacer (DEVICE).
Who is sponsoring clinical trial NCT02627794?
This trial is sponsored by Cedars-Sinai Medical Center, which has 339 total clinical trials registered on ClinicalTrials.gov.
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