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ClariFix Rhinitis RCT

NCT04154605 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 133

Last updated 2025-03-26

Study results available
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Summary

A randomized, sham-controlled, single-blind study of cryotherapy as a treatment for chronic rhinitis.

Conditions

  • Chronic Rhinitis

Interventions

DEVICE

ClariFix cryotherapy

Bilateral freeze ablation of nasal tissue using the ClariFix device.

DEVICE

Sham ClariFix cryotherapy

Bilateral sham ablation procedure using the ClariFix device.

Sponsors & Collaborators

  • North American Science Associates Inc.

    collaborator UNKNOWN

  • Stryker Instruments

    lead INDUSTRY

Principal Investigators

  • Anthony DelSignore, MD · Ichan School of Medicine, Mount Sinai, New York, NY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-11-05
Primary Completion
2021-03-31
Completion
2025-01-19
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04154605 on ClinicalTrials.gov