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OpenTrials
Completed

NCT Number: NCT03791489

Multi-Treatment PNN Modulation for Chronic Rhinitis

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Francisco Otolaryngology Medical Group, San Francisco, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Study duration (90-days)

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

Secondary outcomes

  1. Pain Scores

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

    Tolerability of treatment as provided by the participant by verbal report of pain/discomfort during treatment and post treatment using an 11-point scale indicating pain intensity from 0 (no pain) to 10 (worst pain).

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

    Time frame: 30 and 90 days after treatment

    The rTNSS is a validated patient-reported outcome measure consisting of 4 symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each item is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). The total rTNSS is the sum of the 4 symptom scores and has a possible range of 0 to 12 points. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.

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

    Time frame: 30 and 90 days after treatment

    The NOSE survey is a patient-reported outcome measure consisting of 5 nasal symptoms: nasal congestion or stuffiness, nasal blockage or obstruction, trouble breathing through the nose, trouble sleeping, and unable to get enough air through the nose during exercise or exertion. Each symptom is scored using a 5-point scale of 0 (not a problem) to 4 (severe problem). The 5 symptom scores are summed and the total is multiplied by 5 to give a total score that ranges from 0 to 100, with higher scores indicating worse symptoms. The change from baseline is calculated as the follow-up value minus the baseline value. Negative values indicate improved symptoms.

Sponsors and collaborators

Lead sponsor

Arrinex, Inc.

Industry

Registry information

Official study title

Feasibility Study of Multi-Treatment Posterior Nasal Nerve (PNN) Modulation for Treatment of Chronic Rhinitis

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2019
Registry last updated
Jul 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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