Status:
ACTIVE_NOT_RECRUITING
NEUROMARK Randomized Controlled Trial
Lead Sponsor:
Neurent Medical
Conditions:
Chronic Rhinitis
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The NEUROMARK RCT Study is a prospective, multicenter, randomized, sham-controlled, single-blinded, superiority trial.
Eligibility Criteria
Inclusion
- Participant Must:
- 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.
- Primary
Exclusion
- Participant Must Not:
- 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.
Key Trial Info
Start Date :
October 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2025
Estimated Enrollment :
132 Patients enrolled
Trial Details
Trial ID
NCT06128200
Start Date
October 10 2023
End Date
March 1 2025
Last Update
March 25 2025
Active Locations (16)
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1
ExcelENT
Homewood, Alabama, United States, 35204
2
East Alabama ENT
Opelika, Alabama, United States, 36801
3
Sensa Health
Los Angeles, California, United States, 90006
4
Sacramento ENT
Sacramento, California, United States, 95815