Sponsor study identifier
interventional
100
1 country
6
Study Start
March 2, 2017
Actual (reported)Primary Completion
July 31, 2018
Actual (reported)Study Completion
April 6, 2020
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 6, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2, 2017
Actual (reported)June 7, 2017
Actual (reported)June 9, 2017
Actual (reported)July 31, 2018
Actual (reported)November 4, 2019
Actual (reported)April 6, 2020
Actual (reported)Change From Baseline in Symptom Severity
Effectiveness will be assessed by the mean change in nasal symptoms using the 4-symptom rTNSS (reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual patient-rated symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, and 3=Severe. The rTNSS has a possible score of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 24 hours. A change of 1 or more is considered the minimum clinically important difference.
90 days post treatment
Device- and/or Procedure-related Serious Adverse Events
Safety will be evaluated based on the frequency of device- and/or procedure-related serious adverse events
90 days post treatment
Change From Baseline in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
90 days post treatment
Change From Baseline in Symptom Severity
1, 3, 6, 9, 12, 15, 18, 21, and 24 months post procedure
Bilateral ablation of nasal tissue for treatment of chronic rhinitis
Cryoablation in the nasal passageway using the ClariFix Device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
California Sleep Institute
East Palo Alto, California, 94303, United States
Sacramento Ear, Nose, and Throat
Sacramento, California, 95661, United States
San Francisco Otolaryngology Medical Group
San Francisco, California, 94108, United States
Ear, Nose, and Throat Associates of South Florida
Boca Raton, Florida, 33487, United States
Bethlehem Ear, Nose, and Throat
Bethlehem, Pennsylvania, 18017, United States
EVMS Otolaryngology
Norfolk, Virginia, 23507, United States
Chang MT, Song S, Hwang PH. Cryosurgical ablation for treatment of rhinitis: A prospective multicenter study. Laryngoscope. 2020 Aug;130(8):1877-1884. doi: 10.1002/lary.28301. Epub 2019 Sep 30.
Ow RA, O'Malley EM, Han JK, Lam KK, Yen DM. Cryosurgical Ablation for Treatment of Rhinitis: Two-Year Results of a Prospective Multicenter Study. Laryngoscope. 2021 Sep;131(9):1952-1957. doi: 10.1002/lary.29453. Epub 2021 Feb 22.
100 participants (actual enrollment reported by the registry).
First Submitted
June 7, 2017
First Posted
June 9, 2017
Study Start
March 2, 2017
Actual (reported)Primary Completion
Registry of Subject Treated With ClariFix
Contact the study team to confirm eligibility.
July 31, 2018
Actual (reported)Study Completion
April 6, 2020
Actual (reported)Last Updated
March 17, 2021
Results First Posted
November 4, 2019
Record last verified: 2021-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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