Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Registry of Subject Treated With ClariFix (SNIF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03739216
Recruitment Status : Active, not recruiting
First Posted : November 12, 2018
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Arrinex, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Chronic Rhinitis Device: ClariFix

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: A Prospective, Multi-Center Registry of Subjects Treated With the ClariFix Cryotherapy Device
Actual Study Start Date : June 13, 2018
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Group/Cohort Intervention/treatment
Open label
Open label registry study of patients treated with the ClariFix device for chronic rhinitis.
Device: ClariFix
The ClariFix device is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue.




Primary Outcome Measures :
  1. Change in symptom severity [ Time Frame: Post treatment at 3-months ]
    Effectiveness will be assessed by the change in nasal symptoms using the four-symptom TNSS (Total Nasal Symptom Score). The TNSS 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, and 3=Severe. The TNSS has a possible score of 0-12. The TNSS scores are based on the subject's evaluation of symptom severity over the preceding two weeks.

  2. Change in symptom severity [ Time Frame: Post treatment at 6-Weeks ]
    Effectiveness will be assessed by the change in nasal symptoms using the four-symptom TNSS (Total Nasal Symptom Score). The TNSS 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, and 3=Severe. The TNSS has a possible score of 0-12. The TNSS scores are based on the subject's evaluation of symptom severity over the preceding two weeks.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Physicians and staff will invite patients receiving treatment with ClariFix device and who meet enrollment criteria (See Section 6) to participate in the registry. Invited patients that provide informed consent will be enrolled into the registry. Baseline, treatment and follow-up data shall be collected at pre-determined intervals.
Criteria

Inclusion Criteria:

  • Subject is scheduled to receive treatment with the ClariFix device in accordance with the Clarifix instructions for use (LBL-0384).
  • Subject is able to provide consent and willing to adhere to the study visit schedule.

Exclusion Criteria:

  • Subject is scheduled to have additional treatment and/or procedures completed at the same time of treatment with the ClariFix device.
  • Subject is scheduled to have additional nasal or sinus treatments and/or procedures completed within three (3) months of treatment with the ClariFix device.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03739216


Locations
Layout table for location information
United States, California
Del Rey Allergy & Sinus
Bakersfield, California, United States, 93312
Del Rey Allergy & Sinus
Marina Del Rey, California, United States, 90292
Sacramento, Ear, Nose, and Throat
Roseville, California, United States, 95661
UC Davis Dept of Otolaryngology
Sacramento, California, United States, 95817
Breathe Clear Institutue
Torrance, California, United States, 90503
United States, Florida
Light ENT
Boynton Beach, Florida, United States, 33426
Ear, Nose, and Throat Associates of South Florida
Plantation, Florida, United States, 33324
United States, Georgia
North Georgia ENT
Cumming, Georgia, United States, 30040
United States, Illinois
Chicago Nasal & Sinus
Chicago, Illinois, United States, 60602
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Tandem Clinical Research
Marrero, Louisiana, United States, 70072
United States, New York
Albany ENT & Allergy
Albany, New York, United States, 12206
ENT & Allergy/Northwell Health
New York, New York, United States, 10016
Icahn School of Medicine at Mt. Sinai
New York, New York, United States, 10029
United States, North Carolina
Piedmont ENT
Winston-Salem, North Carolina, United States, 27103
United States, Pennsylvania
Bethlehem ENT
Bethlehem, Pennsylvania, United States, 18017
United States, Texas
Texas Healthcare
Fort Worth, Texas, United States, 76104
Collin County ENT
Frisco, Texas, United States, 75034
UT Health
Houston, Texas, United States, 77030
ENT Associates of Texas
McKinney, Texas, United States, 75070
United States, Utah
Ogden Clinic
Ogden, Utah, United States, 84403
United States, Virginia
Metropolitan ENT
Alexandria, Virginia, United States, 22310
United States, Wisconsin
Aurora Health System
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Arrinex, Inc.
Investigators
Layout table for investigator information
Study Director: Meredith Mundy Arrinex, Inc.
Principal Investigator: Amber Luong, MD PHD UT Health - The University of Texas

Additional Information:

Layout table for additonal information
Responsible Party: Arrinex, Inc.
ClinicalTrials.gov Identifier: NCT03739216     History of Changes
Other Study ID Numbers: CT-0004
First Posted: November 12, 2018    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases