CompletedNot Applicable

NEUROMARK Randomized Controlled Trial

United States132 participantsStarted 2023-10-10

Plain-language summary

The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.

Age range18 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 ≥18 years of age.
✓. Have been experiencing rhinitis symptoms for a minimum of 6 months.
✓. Have moderate to severe symptoms of runny nose (individual 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 score of 5 (out of 12) at baseline.
✓. Be an appropriate candidate for bilateral NEUROMARK device treatment performed under local anesthesia.
✓. Be willing and able to comply with all study elements, as indicated by written informed consent.

✕. Have clinically significant anatomic obstruction 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 RF, cryotherapy, or other surgical interventions for rhinitis.
✕. Have rhinitis symptoms that are due to seasonal allergies only.

rTNSS

Timeframe: 90-days post procedure follow-up

NCT IDNCT06128200

SponsorNeurent Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-26