CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
ClariFix Devicedevice
Likely dose
Not stated in record
Key inclusion· 4
  • Age >21 years
  • Moderate to severe rhinorrhea (symptom rating 2-3) AND mild to severe congestion (symptom rating 1-3) with minimum TNSS score of 4, present >6 months
  • Documented allergy test within last 10 years or willing to undergo testing
  • Failed medical management: intranasal steroids used for minimum 4 weeks without adequate symptom relief
Key exclusion· 11
  • Clinically significant anatomic obstruction limiting posterior nasal access (septal deviation, perforation, polyps, sinonasal tumor)
  • Prior sinus or nasal surgery significantly altering posterior nasal anatomy
  • Active nasal or sinus infection
  • Moderate to severe ocular symptoms

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03181594
NCT03181594N/ACompleted

Clinical Evaluation of Safety and Efficacy for the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

Arrinex, Inc.·interventional·Posted Jun 9, 2017·Updated Mar 17, 2021

In Brief

A clinical study evaluating ClariFix Device for Chronic Rhinitis. Completed, enrolled 100 participants across 6 sites.

Detailed Summary

A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedJun 9, 2017
Enrollment StartMar 2, 2017
Primary CompletionJul 31, 2018
Study CompletionApr 6, 2020
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 9.1 years ago

Interventions

ClariFix Devicedevice

Cryoablation in the nasal passageway using the ClariFix Device