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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: Clinical Trial Phase 3 study, sponsored by Cedars-Sinai Medical Center.
NCT02627794 is a Phase 3 study that was terminated before completion, run by Cedars-Sinai Medical Center. The registered enrollment target is 3 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The main objective of the trial is to evaluate basic device usability and confirm safety and effectiveness of Restora™ Mometasone Furoate eluting spacer as compared to a Silastic spacer. 35-day sinonasal mucosal inflammation will be assessed by rigid endoscopy and graded on Lund-Kennedy sinus mucosal endoscopic staging system.
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 |
Why NCT02627794 stopped before completion
NCT02627794 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (100% lower).
The record links to 0 conditions, and to 2 interventions - of which Restora™ Steroid eluting spacer is the first listed.
NCT02627794 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02627794's enrollment target sits among peer trials
3 1999th of 2000 higher than 1 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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