Last updated: June 15, 2021
Sponsor: Aerin Medical
Overall Status: Completed
Phase
N/A
Condition
Allergy
Common Cold
Nasal Obstruction
Treatment
N/AClinical Study ID
NCT03727347
TP668
Ages 22-75 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Age 22 to 75 years (inclusively)
- Willing and able to provide informed consent
- Willing and able to comply with the subject-specific requirements outlined in thestudy protocol
- Seeking treatment for chronic rhinitis symptoms of at least 6 months duration andwilling to undergo an office-based procedure
- Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea)
- Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion)
- rTNSS score of greater than or equal to 6
- Dissatisfaction with medical management, defined as usage of intranasal steroids for aminimum of 4 weeks without adequate symptom relief, as judged by the subject
Exclusion
Exclusion Criteria:
- Anatomic obstructions that in the investigator's opinion limit access to the posteriornose
- Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery orinjury
- Active nasal or sinus infection
- Moderate to severe ocular allergic symptoms (such as eye tearing [epiphora], itching [pruritus], or redness [erythema])
- History of significant dry eye
- History of any of the following: nose bleeds in the past 3 months, rhinitismedicamentosa, head or neck irradiation
- Known or suspected allergies or contraindications to the anesthetic agents and/orantibiotic medications to be used during the study procedure session
- Known or suspected to be pregnant, or is lactating
- Participating in another clinical research study
- Other medical conditions which in the opinion of the investigator would predispose thesubject to poor wound healing, increased surgical risk, or poor compliance with therequirements of the study
Study Design
Total Participants: 50
Study Start date:
October 16, 2018
Estimated Completion Date:
September 17, 2020
Study Description
Connect with a study center
Colorado ENT and Allergy
Colorado Springs, Colorado 80909
United StatesSite Not Available
Advanced ENT and Allergy
New Albany, Indiana 47150
United StatesSite Not Available
Piedmont ENT Associates
Winston-Salem, North Carolina 27103
United StatesSite Not Available
Fort Worth ENT
Fort Worth, Texas 76109
United StatesSite Not Available
ENT and Allergy Associates of Texas
McKinney, Texas 75070
United StatesSite Not Available
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