CompletedNot Applicable

ClariFix Rhinitis RCT

United States133 participantsStarted 2019-11-05

Plain-language summary

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

Age range21 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.

✓. Be ≥21 years of age.
✓. Has been diagnosed with chronic nonallergic or allergic rhinitis.
✓. Have moderate to severe symptoms of rhinorrhea (individual reflective Total Nasal Symptoms Score \[rTNSS\] symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total rTNSS of 4 (out of 12) at baseline.
✓. Have an allergy test (by skin prick or intradermal testing or by validated in vitro tests for specific Immunoglobin E \[IgE\]) on file within 12 months of the baseline visit.
✓. Be an appropriate candidate for bilateral ClariFix treatment performed under local anesthesia.
✓. Be willing and able to comply with all study elements, as indicated by their written informed consent.
✓. Be willing and able to comply with all study elements and provide written consent.

✕. Have clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
✕. Have had previous sinus or nasal surgery within 6 months of study enrollment.
✕. Have previously undergone cryotherapy or other surgical interventions for rhinitis.
✕. Have an active nasal or sinus infection.
✕. Have rhinitis symptoms that are primarily due to seasonal allergies.
✕. Have plans to (or otherwise anticipates the need to) undergo an ENT (ear, nose, throat) procedure concurrently or within 3 months after the study procedure.
✕. Is on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure (81 mg aspirin and herbal supplements are acceptable).
✕. Be unable to discontinue ipratropium bromide (IB) at least 14 days before baseline and through the 90-day follow-up visit.

rTNSS Responder Rate

Timeframe: 90-days post treatment

NCT IDNCT04154605

SponsorStryker Instruments

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-31

Results submitted2021-08-24

Who can participate

Age range21 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.

✓. Be ≥21 years of age.
✓. Has been diagnosed with chronic nonallergic or allergic rhinitis.
✓. Have moderate to severe symptoms of rhinorrhea (individual reflective Total Nasal Symptoms Score \[rTNSS\] symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rTNSS symptom rating of 1, 2, or 3), and a minimum total rTNSS of 4 (out of 12) at baseline.
✓. Have an allergy test (by skin prick or intradermal testing or by validated in vitro tests for specific Immunoglobin E \[IgE\]) on file within 12 months of the baseline visit.
✓. Be an appropriate candidate for bilateral ClariFix treatment performed under local anesthesia.
✓. Be willing and able to comply with all study elements, as indicated by their written informed consent.
✓. Be willing and able to comply with all study elements and provide written consent.

✕. Have clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor.
✕. Have had previous sinus or nasal surgery within 6 months of study enrollment.
✕. Have previously undergone cryotherapy or other surgical interventions for rhinitis.
✕. Have an active nasal or sinus infection.
✕. Have rhinitis symptoms that are primarily due to seasonal allergies.
✕. Have plans to (or otherwise anticipates the need to) undergo an ENT (ear, nose, throat) procedure concurrently or within 3 months after the study procedure.
✕. Is on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be discontinued before the procedure (81 mg aspirin and herbal supplements are acceptable).
✕. Be unable to discontinue ipratropium bromide (IB) at least 14 days before baseline and through the 90-day follow-up visit.