Multi-Treatment PNN Modulation for Chronic Rhinitis

NCT03791489 | Completed Results FDA Device

• 1 other identifier: CT-0005
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

Brief Summary

Feasibility of treatment at multiple sites with the ClariFix cryoablation device for treatment of chronic rhinitis

Conditions

Chronic Rhinitis

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Procedure-related Serious Adverse Events (SAEs) and/or Serious Adverse Device Effects (SADE)

  The outcome measure is the number of participants experiencing 1 or more SAEs/SADEs.

  Study duration (90-days)

Secondary Outcomes (3)

• Pain Scores

  Day of treatment during procedure and for up to 1 hour post procedure

• Change From Baseline in the Reflective Total Nasal Symptom Score (rTNSS)

  30 and 90 days after treatment

• Change From Baseline in the Overall Nasal Obstruction Symptom Evaluation (NOSE) Score

  30 and 90 days after treatment

Study Arms (1)

Active Treatment

EXPERIMENTAL

Cryotherapy of the posterior nasal nerve using the ClariFix device

Device: ClariFix

Interventions

ClariFix DEVICE

The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.

Active Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of moderate to severe rhinorrhea symptoms and mild to severe nasal congestion symptoms for \>3 months.
• Documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens, or is willing to have one performed prior to study exit.
• Able to provide informed consent and willing to complete study activities and visits per protocol.

You may not qualify if:

• Clinically significant anatomic obstructions that limit access to the posterior nose.
• Prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
• Moderate to severe ocular symptoms as determined.
• History of epistaxis in the past 3 months.
• History of rhinitis medicamentosa.
• Prior head or neck irradiation.
• Active or chronic nasal or sinus infection.
• Pregnant.
• Allergy or intolerance to anesthetic agent.
• Cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
• Currently participating in another clinical research study.
• Any physical condition that, in the investigator's opinion, would prevent adequate study participation or pose increased risk.

Sponsors & Collaborators

• Arrinex, Inc.: lead

Study Sites (3)

San Francisco Otolaryngology Medical Group

San Francisco, California, 94108, United States

Location

Bethlehem ENT

Bethlehem, Pennsylvania, 18017, United States

Location

Tracy Byerly, MD

Fredericksburg, Texas, 78624, United States

Location

Results Point of Contact

• Title: Pr. Clinical Research & Publications Manager
• Organization: Stryker ENT

ellen.omalley@stryker.com

763-463-1598

Study Officials

• David Yen, MD

  Specialty Physician Associates

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, non-randomized, feasibility study of multi-treatment locations

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 2, 2019
• Study Start: December 1, 2018
• Primary Completion: July 18, 2019
• Study Completion: July 18, 2019
• Last Updated: July 24, 2020
• Results First Posted: July 24, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)