Active — Not RecruitingNot Applicable

NEUROMARK Registry Study

United States150 participantsStarted 2023-06-12

Plain-language summary

The NEUROMARK Registry Study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the NEUROMARK System in subjects with chronic rhinitis.

Who can participate

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.

Inclusion criteria

✓. Be ≥18 years of age.
✓. Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
✓. Have moderate to severe symptoms of running 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 screening.
✓. Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.

What they're measuring

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 3-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 6-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 12-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 18-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 24-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 30-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 36-month follow-up

Efficacy - reflective Total Nasal Symptom Score (rTNSS)

Trial details

NCT IDNCT05937308

SponsorNeurent Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Chronic Rhinitis trials

Who can participate

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.

Inclusion criteria

✓. Be ≥18 years of age.
✓. Be scheduled to receive treatment with the commercially available NEUROMARK System consistent with the device's indications for use.
✓. Have moderate to severe symptoms of running 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 screening.
✓. Be willing and able to provide consent and comply with all study elements, as indicated by written informed consent.

What they're measuring

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 3-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 6-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 12-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 18-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 24-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 30-month follow-up

Safety - incidence of device- and/or procedure-related serious adverse

Timeframe: 36-month follow-up

Efficacy - reflective Total Nasal Symptom Score (rTNSS)