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The CLARITY Study is a prospective, single-arm, multicenter safety and efficacy study of the Neurent Medical NEUROMARK System in subjects with chronic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: Treatment | Experimental | Subjects will undergo treatment with the NEUROMARK System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NEUROMARK System | Device | The NEUROMARK™ System is indicated for use in otorhinolaryngology (ENT) surgery for creation of radiofrequency (RF) lesions to disrupt posterior nasal nerves in patients with chronic rhinitis. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Device- or Procedure-related Serious Adverse Events (SAEs) Within 1 Month | SAEs were defined per ICH-GCP (E6). This measure includes all SAEs assessed by the investigator as related to the device and/or procedure within 1 month post-procedure. | 1 month |
| Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Rhinorrhea at 3 Months | The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for [rhinorrhea / nasal congestion]. A negative change from baseline indicates improvement. | 3 months |
| Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Nasal Congestion at 3 Months | The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for [rhinorrhea / nasal congestion]. A negative change from baseline indicates improvement. | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annalise Sorensen | Neurent Medical | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alabama Nasal and Sinus Center | Birmingham | Alabama | 35242 | United States | ||
| Centers for Advanced ENT Care |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38835333 | Derived | Reh DD, Lay K, Davis G, Dubin MG, Yen DM, O'Malley EM, Sillers M. Long-term outcomes following impedance-controlled radiofrequency ablation for the treatment of chronic rhinitis. Laryngoscope Investig Otolaryngol. 2024 Jun 4;9(3):e1286. doi: 10.1002/lio2.1286. eCollection 2024 Jun. | |
| 37090860 | Derived | Reh DD, Lay K, Davis G, Dubin MG, Yen DM, O'Malley EM, Sillers M. Clinical evaluation of a novel multipoint radiofrequency ablation device to treat chronic rhinitis. Laryngoscope Investig Otolaryngol. 2023 Mar 16;8(2):367-372. doi: 10.1002/lio2.1040. eCollection 2023 Apr. |
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Participants who met eligibility criteria were enrolled and assigned to receive treatment with the NEUROMARK System. One participant was lost to follow-up after the 3-month visit.
Participants with chronic rhinitis were enrolled in a prospective, single-arm study evaluating the NEUROMARK System.
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| ID | Title | Description |
|---|---|---|
| FG000 | NEUROMARK Treatment | Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NEUROMARK Treatment | Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Device- or Procedure-related Serious Adverse Events (SAEs) Within 1 Month | SAEs were defined per ICH-GCP (E6). This measure includes all SAEs assessed by the investigator as related to the device and/or procedure within 1 month post-procedure. | Posted | Count of Participants | Participants | 1 month |
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from enrollment until end of follow-up, 12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NEUROMARK Treatment | Participants with chronic rhinitis underwent treatment with the NEUROMARK System in this single-arm study. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pain/discomfort | General disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annalise Sorensen | Neurent Medical | 3038811757 | annalise@neurentmedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2022 | Apr 17, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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A prospective, single-arm, multicenter clinical study
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| Baltimore |
| Maryland |
| 21204 |
| United States |
| Specialty Physician Associates | Bethlehem | Pennsylvania | 18017 | United States |
| ENT & Allergy Associcates | Puyallup | Washington | 98374 | United States |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Severity of Chronic Rhinitis | Severity of chronic rhinitis was assessed by the treating investigator at screening based on patient-reported symptom burden using the VAS NSS and rTNSS. Mild: minimal symptoms not significantly impacting daily function. Moderate: symptoms interfering with daily activities, requiring symptomatic treatment. Severe: symptoms causing significant impairment of daily activities, requiring treatment. All enrolled participants met inclusion criteria requiring at least moderate rhinorrhea (VAS NSS ≥ 5.0, rTNSS ≥ 2) and mild to severe nasal congestion (VAS NSS ≥ 2.5, rTNSS ≥ 1). | Count of Participants | Participants |
|
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| Primary | Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Rhinorrhea at 3 Months | The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for [rhinorrhea / nasal congestion]. A negative change from baseline indicates improvement. | Posted | Mean | Standard Deviation | Score | 3 months |
|
|
|
| Primary | Mean Change From Baseline in VAS Nasal Symptom Score (NSS) for Nasal Congestion at 3 Months | The Visual Analog Scale Nasal Symptom Score (VAS NSS) is a patient-reported outcome measure of nasal symptom severity. Each symptom item is scored on a scale of 0 to 10, where 0 indicates no symptoms and 10 indicates the worst possible symptoms; higher scores indicate worse outcomes. This measure reports the mean change from baseline to 3 months in VAS NSS for [rhinorrhea / nasal congestion]. A negative change from baseline indicates improvement. | Posted | Mean | Standard Deviation | Score | 3 months |
|
|
|
| 0 |
| 36 |
| 0 |
| 36 |
| 2 |
| 36 |
| Sinus Infection | Infections and infestations | Systematic Assessment |
|
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| D010038 |
| Otorhinolaryngologic Diseases |