NCT02820597

ClariFix Cryoablation Clinical Study

Completed NA Results posted Last updated 21 October 2019

What this trial tests

NA trial testing ClariFix device in Rhinitis in 27 participants. Completed in 20 July 2016.

Timeline

15 June 2015

Primary endpoint
5 February 2016

20 July 2016

Quick facts

Lead sponsor	Arrinex, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	27
Start date	15 June 2015
Primary completion	5 February 2016
Estimated completion	20 July 2016

Drugs / interventions tested

• ClariFix device

Conditions studied

• Rhinitis — all drugs for Rhinitis →

Sponsor

Arrinex, Inc.

Who can join

21 and older, any sex, with Rhinitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Device- and/or Procedure-related Serious Adverse Events Primary · Baseline through 365 days post treatment

Number of participants with device- and/or procedure-related serious adverse events reported over the initial study follow-up period.

Group	Value	95% CI
Intervention	0

Change in Rhinitis Symptom Severity (rTNSS) Primary · Baseline through 365 days post treatment

Change from baseline in participant-reported symptom severity based on the rTNSS (Reflective Total Nasal Symptom Score). The rTNSS is the sum of 4 individual subject-assessed symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing, each evaluated using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe. The rTNSS has a possible score range of 0-12. The reflective scores are based on the participant's evaluation of symptom severity over the preceding 12 hours.

7 Days post treatment

Group	Value	95% CI
Intervention	-1.9	± 0.6

30 Days post treatment

Group	Value	95% CI
Intervention	-3.6	± 0.6

90 Days post treatment

Group	Value	95% CI
Intervention	-3.3	± 0.6

180 Days post treatment

Group	Value	95% CI
Intervention	-4.0	± 0.5

365 Days post treatment

Group	Value	95% CI
Intervention	-4.5	± 0.3

Change in Rhinitis Symptoms (VAS) Primary · Baseline through 365 days post treatment

Change from baseline in rhinitis symptoms measured on a participant-reported visual analog scale (VAS). Symptoms of rhinorrhea, nasal breathing, facial pain/pressure, and sense of smell were rated from 0 (no symptoms) to 10 (severe/extremely bothersome symptoms) assessed over the 12 hours preceding the visit. An average of the 4 individual scores was used as the total VAS score with a range of 0 to 10.

7 Days post treatment

Group	Value	95% CI
Intervention	-2.1	± 0.5

30 Days post treatment

Group	Value	95% CI
Intervention	-3.8	± 0.5

90 Days post treatment

Group	Value	95% CI
Intervention	-4.1	± 0.6

180 Days post treatment

Group	Value	95% CI
Intervention	-2.9	± 0.7

365 Days post treatment

Group	Value	95% CI
Intervention	-5.6	± 1.1

Ease of Use Secondary · Immediately post treatment

Physician evaluation of ClariFix ease of use. After each participant's treatment, the physician was asked to rate the ClariFix on ease of use. Options were easy, moderately easy, moderately difficult, or difficult.

Group	Value	95% CI
Intervention	14
Intervention	10
Intervention	3
Intervention	0

Device- and/or Procedure-related Adverse Events Secondary · Baseline through 90 days post treatment

All adverse events evaluated as possibly, probably, or definitely related to the ClariFix device and/or procedure.

Group	Value	95% CI
Intervention	1

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 Year. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Intervention

Serious: 0/27 (0%)

Deaths: 0/27

Other adverse events (3 terms — click to expand)

Reaction	System	Intervention
Ear blockage	General disorders	—
Nasal Dryness	General disorders	—
Epitaxsis	General disorders	—

Data from ClinicalTrials.gov NCT02820597 adverse events section.

Sponsor's own description

This is a single-arm pilot study designed to evaluate the feasibility of cryoablation in the nasal passageway, using the ClariFix device, to reduce the symptoms of chronic rhinitis.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.