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OpenTrials
Completed

NCT Number: NCT03739216

Registry of Subject Treated With ClariFix

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.

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Key information

Conditions

Chronic Rhinitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Del Rey Allergy & Sinus, Bakersfield, 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

  • 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.

Treatment and study plan

ClariFix

Device

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

Primary outcomes

  1. Change from baseline in nasal symptom severity

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

    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.

Secondary outcomes

  1. Patient-assessed improvement in nasal symptoms

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

    Percentage of participants reporting their change from baseline as minimally improved, much improved, or very much improved using the Patient Global Impression of Change (PGIC) assessment. The PGIC has patients evaluate their improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse).

  2. Clinician-assessed improvement in nasal symptoms

    Time frame: Follow-up visit at 3 months post treatment

    Percentage of clinicians reporting their participants change in nasal symptoms from baseline as minimally improved, much improved, or very much improved using the Clinical Global Impression - Improvement (CGI-I) assessment. The CGI-I has clinicians rate their patient's improvement over baseline on a scale from 1 (very much improved) to 7 (very much worse).

Sponsors and collaborators

Lead sponsor

Arrinex, Inc.

Industry

Registry information

Official study title

A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device

Acronym: SNIF

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Nov 13, 2018
Registry last updated
Aug 3, 2021

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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