Registry of Subject Treated With ClariFix

NCT ID: NCT03739216

Last Updated: 2021-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

354 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-13

Study Completion Date

2021-06-15

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Rhinitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Open label

Open label registry study of patients treated with the ClariFix device for chronic rhinitis.

ClariFix

Intervention Type DEVICE

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

Interventions

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ClariFix

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arrinex, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Amber U Luong, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UT Health - The University of Texas

Locations

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Del Rey Allergy & Sinus

Bakersfield, California, United States

Site Status

Del Rey Allergy & Sinus

Marina del Rey, California, United States

Site Status

Sacramento, Ear, Nose, and Throat

Roseville, California, United States

Site Status

UC Davis Dept of Otolaryngology

Sacramento, California, United States

Site Status

Breathe Clear Institutue

Torrance, California, United States

Site Status

Light ENT

Boynton Beach, Florida, United States

Site Status

Ear, Nose, and Throat Associates of South Florida

Plantation, Florida, United States

Site Status

North Georgia ENT

Cumming, Georgia, United States

Site Status

Chicago Nasal & Sinus

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Tandem Clinical Research

Marrero, Louisiana, United States

Site Status

Albany ENT & Allergy

Albany, New York, United States

Site Status

ENT & Allergy/Northwell Health

New York, New York, United States

Site Status

Icahn School of Medicine at Mt. Sinai

New York, New York, United States

Site Status

Piedmont ENT

Winston-Salem, North Carolina, United States

Site Status

Bethlehem ENT

Bethlehem, Pennsylvania, United States

Site Status

Texas Healthcare

Fort Worth, Texas, United States

Site Status

Collin County ENT

Frisco, Texas, United States

Site Status

UT Health

Houston, Texas, United States

Site Status

ENT Associates of Texas

McKinney, Texas, United States

Site Status

Ogden Clinic

Ogden, Utah, United States

Site Status

Metropolitan ENT

Alexandria, Virginia, United States

Site Status

Aurora Health System

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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CT-0004

Identifier Type: -

Identifier Source: org_study_id

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