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NCT03534362 · ClinicalTrials.gov registry record · NA
Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out
A NA study, sponsored by St. Louis University.
- Terminated
- Registry status
- NA
- Development phase
- 1
- Enrollment target
NCT03534362 is a NA study that was terminated before completion, run by St. Louis University. The registered enrollment target is 1 participants.
The verdict
NCT03534362, a NA study, was terminated before completion, sponsored by St. Louis University.
- TERMINATED
- Registry status
- NA
- Development phase
- 1 participants
- Enrollment target
Study Summary
Surgery on the frontal sinus is done for patients who have sinus problems that do not respond to medications. It involves making an opening within the right and left frontal sinus of the nose to help it drain. For severe frontal sinus disease, the sinus is widely opened and the left and right sinuses become one large sinus. This is done with sharp instruments and rigid endoscopes placed through the nostrils. While the sinus heals after surgery, a stent or steroids or both may be used to try to help make sure that the opening does not close back up. Two current options for this are Propel stents and steroid-soaked Nasopore. Propel stents are FDA-approved. Nasopore and Kenalog injection are both FDA-approved, but their use together is part of the study and not specifically FDA-approved. A previous study shows that Propel stents are useful to reduce scarring in other frontal sinus procedures. We would like to know whether this is true in larger frontal sinus surgery where one common cavity is made and whether both steroid-containing stents are the same.
Interventions
- DEVICE Nasopore
- DEVICE Propel
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2018-04-13 |
| Est. Completion | 2019-09-23 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03534362
The ClinicalTrials.gov registry entry for NCT03534362 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Louis University, which has 107 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Nasopore is the first listed.
NCT03534362 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03534362 about?
NCT03534362 is a clinical study titled "Propel Stent vs Kenalog-soaked Nasopore After Frontal Drill-out". Surgery on the frontal sinus is done for patients who have sinus problems that do not respond to medications. It involves making an opening within the right and left frontal sinus of the nose to help it drain. For severe frontal sinus disease, the sinus is widely opened and the left and right sinuse...
What is the current status of trial NCT03534362?
This trial is currently terminated. It is a NA study. The enrollment target is 1 participants. The study started on 2018-04-13. Estimated completion is 2019-09-23.
What interventions are being tested in trial NCT03534362?
The interventions under investigation include: Nasopore (DEVICE), Propel (DEVICE).
Who is sponsoring clinical trial NCT03534362?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
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