Multi-Treatment PNN Modulation for Chronic Rhinitis

NCT ID: NCT03791489

Last Updated: 2020-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-07-18

Brief Summary

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

Conditions

Chronic Rhinitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active Treatment

Cryotherapy of the posterior nasal nerve using the ClariFix device

Group Type: EXPERIMENTAL

ClariFix

Intervention Type: 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.

Interventions

ClariFix

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Arrinex, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Yen, MD

Role: PRINCIPAL_INVESTIGATOR

Specialty Physician Associates

Locations

San Francisco Otolaryngology Medical Group

San Francisco, California, United States

Bethlehem ENT

Bethlehem, Pennsylvania, United States

Tracy Byerly, MD

Fredericksburg, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CT-0005

Identifier Type: -

Identifier Source: org_study_id