CompletedNot Applicable

Clinical Evaluation of Safety and Efficacy for the NEUROMARK System in Subjects With Chronic Rhinitis (PARAGON)

United States80 participantsStarted 2022-09-26

Plain-language summary

The PARAGON Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Have an allergy test (by skin prick or intradermal testing, or by a validated in vitroImmunoglobin E \[IgE test\]) on file within 5 years of the baseline visit or is willing to have one performed during the study prior to 6-month visit.
✓. Be an appropriate candidate for bilateral NEUROMARK® device treatment performed under local anesthesia.
✓. Test negative for active COVID-19 at the start of the study screening and continue to be free of COVID-19 symptoms until the time of enrollment/treatment.
✓. Be willing and able to comply with all study elements, as indicated by written informed consent.

Exclusion criteria

✕. 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 an active nasal or sinus infection.
✕. Have nasal mucosal erosion/ulceration.
✕. Have rhinitis symptoms that are due to seasonal allergies only.
✕. Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or within 6 months after the study procedure.
✕. Have started a new sinonasal medication regimen within 4 weeks prior to treatment that, according to the manufacturer's labelling, has not yet stabilized.

What they're measuring

Safety Outcome

Timeframe: 24 months

Efficacy Outcome

Timeframe: 6 months

Trial details

NCT IDNCT05591989

SponsorNeurent Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-08-05

View on ClinicalTrials.gov More Chronic Rhinitis trials