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NCT04154605 · ClinicalTrials.gov registry record · NA
ClariFix Rhinitis RCT
A NA study of Chronic Rhinitis, sponsored by Stryker Instruments.
- Completed
- Registry status
- NA
- Development phase
- 133
- Enrollment target
- 1
- Study location
NCT04154605: Completed NA study of Chronic Rhinitis, sponsored by Stryker Instruments.
NCT04154605 is a NA study of Chronic Rhinitis that has completed, run by Stryker Instruments. The registered enrollment target is 133 participants, above the 75-participant average among 6 other Chronic Rhinitis trials with a reported enrollment target (77% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04154605, a NA study of Chronic Rhinitis, has completed, sponsored by Stryker Instruments.
- COMPLETED
- Registry status
- NA
- Development phase
- 133 participants
- Enrollment target
- 1
- Study location
Study Summary
A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
Primary Outcome
Responders are defined as participants with a 30% or greater reduction in reflective Total Nasal Symptom Score (rTNSS) relative to baseline. The active treatment will be compared with the sham treatment. The reflective Total Nasal Symptom Score (rTNSS) is a validated PRO consisting of 4 nasal symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing that are assessed over the previous 2-week period. Each symptom is rated on a scale of 0 (no symptoms) to 3 (severe symptoms) an
Conditions Studied
Interventions
- DEVICE ClariFix cryotherapy
- DEVICE Sham ClariFix cryotherapy
Study Locations (1)
Florida
- ENT Associates of South Florida - Coral Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2019-11-05 |
| Est. Completion | 2025-01-19 |
| Phase | NA |
What the finished NCT04154605 record still lists
NCT04154605 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, above the 75-participant average among 6 other Chronic Rhinitis trials with a reported enrollment target (77% higher).
The record links to 1 condition, with Chronic Rhinitis appearing as the primary indexed condition, and to 2 interventions - of which ClariFix cryotherapy is the first listed.
NCT04154605 reports a single indexed study location in Florida.
Frequently Asked Questions
What is clinical trial NCT04154605 about?
NCT04154605 is a clinical study titled "ClariFix Rhinitis RCT". A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.
What is the current status of trial NCT04154605?
This trial is currently completed. It is a NA study. The enrollment target is 133 participants. The study started on 2019-11-05. Estimated completion is 2025-01-19.
What conditions does trial NCT04154605 study?
This clinical trial studies the following conditions: Chronic Rhinitis.
What interventions are being tested in trial NCT04154605?
The interventions under investigation include: ClariFix cryotherapy (DEVICE), Sham ClariFix cryotherapy (DEVICE).
Who is sponsoring clinical trial NCT04154605?
This trial is sponsored by Stryker Instruments, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04154605 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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