Registry of Subject Treated With ClariFix

Chronic Rhinitis Clinical Trial

— SNIF  

Official title:

A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03739216
• Other study ID #: CT-0004
• Status: Completed
• Start date: June 13, 2018
• Est. completion date: June 15, 2021

Study information

• Verified date: July 2021
• Source: Arrinex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

A multi-center, prospective, non-randomized, observational registry to asses the results of the ClariFix(TM) device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 354
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Participant is scheduled to receive treatment with the ClariFix device in accordance with the ClariFix Instructions for Use.
• Participant is able to provide consent and willing to adhere to the study visit schedule.

Exclusion Criteria:

• Participant is scheduled to have additional treatment and/or procedures completed at the same time of treatment with the ClariFix device.
• Participant is scheduled to have additional nasal or sinus treatments and/or procedures completed within 3 months of treatment with the ClariFix device.

Related Conditions & MeSH terms

• Chronic Rhinitis
• Rhinitis

Intervention

Device:
• ClariFix
The ClariFix device is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue.

Locations

Country	Name	City	State
United States	Albany ENT & Allergy	Albany	New York
United States	Metropolitan ENT	Alexandria	Virginia
United States	Del Rey Allergy & Sinus	Bakersfield	California
United States	Bethlehem ENT	Bethlehem	Pennsylvania
United States	Light ENT	Boynton Beach	Florida
United States	Chicago Nasal & Sinus	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	North Georgia ENT	Cumming	Georgia
United States	Texas Healthcare	Fort Worth	Texas
United States	Collin County ENT	Frisco	Texas
United States	UT Health	Houston	Texas
United States	Del Rey Allergy & Sinus	Marina Del Rey	California
United States	Tandem Clinical Research	Marrero	Louisiana
United States	ENT Associates of Texas	McKinney	Texas
United States	Aurora Health System	Milwaukee	Wisconsin
United States	ENT & Allergy/Northwell Health	New York	New York
United States	Icahn School of Medicine at Mt. Sinai	New York	New York
United States	Ogden Clinic	Ogden	Utah
United States	Ear, Nose, and Throat Associates of South Florida	Plantation	Florida
United States	Sacramento, Ear, Nose, and Throat	Roseville	California
United States	UC Davis Dept of Otolaryngology	Sacramento	California
United States	Breathe Clear Institutue	Torrance	California
United States	Piedmont ENT	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Arrinex, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in nasal symptom severity	Effectiveness will be assessed by the change from baseline in nasal symptoms using the TNSS (Total Nasal Symptom Score). The TNSS is a patient-reported assessment of 4 symptom scores for rhinorrhea (runny nose), nasal congestion, nasal itching, and sneezing. Each symptom is rated on a scale of 0 (none) to 3 (severe). The symptom scores are summed to give a total TNSS score that can range from 0 to 12.	Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
Secondary	Patient-assessed improvement in nasal symptoms	Percentage of participants reporting their change from baseline as minimally improved, much improved, or very much improved using the Patient Global Impression of Change (PGIC) assessment. The PGIC has patients evaluate their improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse).	Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
Secondary	Clinician-assessed improvement in nasal symptoms	Percentage of clinicians reporting their participants change in nasal symptoms from baseline as minimally improved, much improved, or very much improved using the Clinical Global Impression - Improvement (CGI-I) assessment. The CGI-I has clinicians rate their patient's improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse).	Follow-up visit at 3 months post treatment