Clinical trial NCT03739216: Registry of Subject Treated With ClariFix
Official title: A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinitis
Lead sponsor: Arrinex, Inc.
Sponsor class: INDUSTRY
First posted: 2018-11-13
Enrollment: 354
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Physicians and staff will invite patients receiving treatment with ClariFix device and who meet enrollment criteria to participate in the registry. Invited patients who provide informed consent will be enrolled into the registry. Baseline, treatment, and follow-up data will be collected at predetermined intervals.

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in nasal symptom severity
timeFrame: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
Secondary outcomes:
measure: Patient-assessed improvement in nasal symptoms
timeFrame: Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment
measure: Clinician-assessed improvement in nasal symptoms
timeFrame: Follow-up visit at 3 months post treatment
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Del Rey Allergy & Sinus
state: California
city: Marina Del Rey
country: United States
facility: Del Rey Allergy & Sinus
state: California
city: Roseville
country: United States
facility: Sacramento, Ear, Nose, and Throat
state: California
city: Sacramento
country: United States
facility: UC Davis Dept of Otolaryngology
state: California
city: Torrance
country: United States
facility: Breathe Clear Institutue
state: California
city: Boynton Beach
country: United States
facility: Light ENT
state: Florida
city: Plantation
country: United States
facility: Ear, Nose, and Throat Associates of South Florida
state: Florida
city: Cumming
country: United States
facility: North Georgia ENT
state: Georgia
city: Chicago
country: United States
facility: Chicago Nasal & Sinus
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Marrero
country: United States
facility: Tandem Clinical Research
state: Louisiana
city: Albany
country: United States
facility: Albany ENT & Allergy
state: New York
city: New York
country: United States
facility: ENT & Allergy/Northwell Health
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Winston-Salem
country: United States
facility: Piedmont ENT
state: North Carolina
city: Bethlehem
country: United States
facility: Bethlehem ENT
state: Pennsylvania
city: Fort Worth
country: United States
facility: Texas Healthcare
state: Texas
city: Frisco
country: United States
facility: Collin County ENT
state: Texas
city: Houston
country: United States
facility: UT Health
state: Texas
city: McKinney
country: United States
facility: ENT Associates of Texas
state: Texas
city: Ogden
country: United States
facility: Ogden Clinic
state: Utah
city: Alexandria
country: United States
facility: Metropolitan ENT
state: Virginia
city: Milwaukee
country: United States
facility: Aurora Health System
state: Wisconsin
Study officials:
affiliation: UT Health - The University of Texas
name: Amber U Luong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: