Registry of Subject Treated With ClariFix

NCT03739216 | Completed FDA Device

• 1 other identifier: CT-0004
• Study Type: observational
• Target: 354
• Locations: 1 country
• Sites: 23

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.

Conditions

Chronic Rhinitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Patient-assessed improvement in nasal symptoms

  Follow-up visits at 6 weeks, 3, 6, 9, 12, 15, 18, 21, and 24 months post treatment

• Clinician-assessed improvement in nasal symptoms

  Follow-up visit at 3 months post treatment

Study Arms (1)

Open label

Open label registry study of patients treated with the ClariFix device for chronic rhinitis.

Device: ClariFix

Interventions

ClariFix DEVICE

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

Open label

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Arrinex, Inc.: lead

Study Sites (23)

Del Rey Allergy & Sinus

Bakersfield, California, 93312, United States

Location

Del Rey Allergy & Sinus

Marina del Rey, California, 90292, United States

Location

Sacramento, Ear, Nose, and Throat

Roseville, California, 95661, United States

Location

UC Davis Dept of Otolaryngology

Sacramento, California, 95817, United States

Location

Breathe Clear Institutue

Torrance, California, 90503, United States

Location

Light ENT

Boynton Beach, Florida, 33426, United States

Location

Ear, Nose, and Throat Associates of South Florida

Plantation, Florida, 33324, United States

Location

North Georgia ENT

Cumming, Georgia, 30040, United States

Location

Chicago Nasal & Sinus

Chicago, Illinois, 60602, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Albany ENT & Allergy

Albany, New York, 12206, United States

Location

ENT & Allergy/Northwell Health

New York, New York, 10016, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Piedmont ENT

Winston-Salem, North Carolina, 27103, United States

Location

Bethlehem ENT

Bethlehem, Pennsylvania, 18017, United States

Location

Texas Healthcare

Fort Worth, Texas, 76104, United States

Location

Collin County ENT

Frisco, Texas, 75034, United States

Location

UT Health

Houston, Texas, 77030, United States

Location

ENT Associates of Texas

McKinney, Texas, 75070, United States

Location

Ogden Clinic

Ogden, Utah, 84403, United States

Location

Metropolitan ENT

Alexandria, Virginia, 22310, United States

Location

Aurora Health System

Milwaukee, Wisconsin, 53215, United States

Location

Study Officials

• Amber U Luong, MD, PhD

  UT Health - The University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: November 13, 2018
• Study Start: June 13, 2018
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: August 3, 2021

Record last verified: 2021-07

Locations

US (23)