CompletedNot Applicable

RhinAer Procedure for Treatment of Chronic Rhinitis Study

United States116 participantsStarted 2020-07-31

Plain-language summary

The purpose of this study is to compare the RhinAer procedure with radiofrequency (RF) energy to sham procedure for treatment of chronic rhinitis.

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18 to 85 years (inclusively).
✓. Willing and able to provide informed consent.
✓. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
✓. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing 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 ≥ 6.

✕. Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
✕. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
✕. Active nasal or sinus infection.
✕. History of significant dry eye.
✕. History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
✕. Have rhinitis symptoms only on a seasonal basis due to allergies.
✕. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
✕. Known or suspected to be pregnant or is lactating.

Reflective Total Nasal Symptom Score (rTNSS) Responder Rate

Timeframe: 3 months visit following the study procedure.

NCT IDNCT04533438

SponsorAerin Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-04-09

Results submitted2022-08-15

Who can participate

Age range18 Years – 85 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age 18 to 85 years (inclusively).
✓. Willing and able to provide informed consent.
✓. Willing and able to comply with the subject-specific requirements outlined in the Study Protocol.
✓. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing 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 ≥ 6.

✕. Anatomic obstructions that in the investigator's opinion limit access to the posterior nasal passage.
✕. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury.
✕. Active nasal or sinus infection.
✕. History of significant dry eye.
✕. History of any of the following: chronic epistaxis, documented episodes of significant nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation.
✕. Have rhinitis symptoms only on a seasonal basis due to allergies.
✕. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
✕. Known or suspected to be pregnant or is lactating.