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Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis
This is a non-significant risk, prospective, multi-center, non-randomized study to evaluate the safety and efficacy of the Aerin Medical device (InSeca Stylus) when used to deliver radiofrequency (RF) energy to the posterior nasal nerve area to improve symptoms in those diagnosed with chronic rhinitis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InSeca Stylus Treatment Group | Experimental | Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InSeca Stylus | Device | Low power radiofrequency energy delivery to the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Reflective Total Nasal Symptom Score (rTNSS) | Mean change in Reflective Total Nasal Symptoms Score (rTNSS) from baseline to 12 weeks post-study procedure. Improvement (12 week score - baseline score) is signified by a negative value. The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in the rTNSS total score from Baseline to 12 week follow up visit | Comparison of scores at Baseline and 12 weeks post procedure |
| Percentage of Participants With Treatment Related Adverse Events (Safety) | Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure. Subjects were asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. Each event was documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. This measure includes any subject who experienced at least one event considered definitely, probably, or possibly related to the device or procedure. | At or following the study procedure, and up to the final study visit at 1 year. |
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| Measure | Description | Time Frame |
|---|---|---|
| rTNSS Responder Rate | The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. Subjects who showed at least a 1 point improvement (decrease) in the reflective Total Nasal Symptom Score (rTNSS) were categorized as responders. An overall responder rate of at least 55% was expected. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| V. Vasu Kakarlapudi, MD | Advanced ENT and Allergy, New Albany, IN | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Colorado ENT and Allergy | Colorado Springs | Colorado | 80909 | United States | ||
| Advanced ENT and Allergy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16719251 | Background | Quillen DM, Feller DB. Diagnosing rhinitis: allergic vs. nonallergic. Am Fam Physician. 2006 May 1;73(9):1583-90. | |
| 18662584 | Background | Wallace DV, Dykewicz MS, Bernstein DI, Blessing-Moore J, Cox L, Khan DA, Lang DM, Nicklas RA, Oppenheimer J, Portnoy JM, Randolph CC, Schuller D, Spector SL, Tilles SA; Joint Task Force on Practice; American Academy of Allergy; Asthma & Immunology; American College of Allergy; Asthma and Immunology; Joint Council of Allergy, Asthma and Immunology. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol. 2008 Aug;122(2 Suppl):S1-84. doi: 10.1016/j.jaci.2008.06.003. No abstract available. |
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Three potential subjects failed to meet one or more of the inclusion/exclusion criteria.
Patients in the specialist's clinic seeking treatment for chronic rhinitis symptoms of at least 6 months duration were approached for possible participation. Following completion of the informed consent process, baseline evaluation was conducted.
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| ID | Title | Description |
|---|---|---|
| FG000 | InSeca Stylus | Low power radiofrequency treatment of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | InSeca Stylus Treatment Group | Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus) |
| 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 | Change in Reflective Total Nasal Symptom Score (rTNSS) | Mean change in Reflective Total Nasal Symptoms Score (rTNSS) from baseline to 12 weeks post-study procedure. Improvement (12 week score - baseline score) is signified by a negative value. The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. This study will measure the mean change in the rTNSS total score from Baseline to 12 week follow up visit | The analyzed population excludes one subject who did not complete the rTNSS questionnaire at the 12 week follow-up visit due to oversight. | Posted | Mean | Standard Deviation | units on a scale | Comparison of scores at Baseline and 12 weeks post procedure |
|
From study procedure through 52-week evaluation
Possible adverse events related to the study procedure were assessed based on physical examinations and queries of the subjects at follow-up evaluations. Details of events were documented on a standardized case report form. Anticipated observations related to the study procedure were recorded but were not categorized as adverse events unless they required mitigation or were of greater severity, duration, or degree of incidence than anticipated.
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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 | InSeca Stylus Treatment Group | Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | unrelated to device or procedure |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anais Laborde | Aerin Medical, Inc. | (650) 518-9624 | alaborde@aerinmedical.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 | Dec 14, 2018 | May 11, 2021 | Prot_SAP_000.pdf |
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All enrolled subjects will be treated with the InSeca Stylus
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| Comparison of scores at Baseline and 12 weeks post procedure |
| Change in rTNSS Over Time | Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients report their symptoms reflected or felt over the last 12 hours. Total scores range from 0 to 12. A higher score indicates increased symptom severity. The mean change in the rTNSS total score from Baseline to each follow up visit: 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure will be recorded. | Baseline to each Follow Up Visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. |
| Change in rTNSS Individual Nasal Symptom Component Scores Over Time | Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. Scores from each of the four components of the questionnaire (rhinorrhea, nasal congestion, nasal itching, and sneezing) will be evaluated at each follow up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. Individual component scores can range from 0 to 3, with a higher score indicating increased symptom severity. | Baseline to each Follow Up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure |
| Response on Aerin Quality-of-Life (QOL) Assessment Items | This Quality-of-Life (QOL) instrument is a 9-item patient self-reported questionnaire developed by Aerin Medical to gain understanding of the impact of chronic rhinitis on daily activities, feelings, symptoms and medication use. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. Section 1 asks "Please indicate how often you experience the following" for 6 items. For items 1, 3, 4 and 5, those who answered "never/rarely" were considered to have a positive (favorable) response. For questions 2 and 6, those who answered "frequently/very frequently" were considered to have a positive (favorable) response. Section 2 requests "Please indicate how often you use each of the following products to help you with your chronic rhinitis". For 3 items in this section, those who answered "never/rarely" were considered to have a positive (favorable) response. | The QOL was to be completed by the subject at baseline prior to the treatment procedure, and at the 12 week, 26 week and 52 week visits post procedure. |
| New Albany |
| Indiana |
| 47150 |
| United States |
| Piedmont ENT Associates | Winston-Salem | North Carolina | 27103 | United States |
| Fort Worth ENT | Fort Worth | Texas | 76109 | United States |
| ENT and Allergy Associates of Texas | McKinney | Texas | 75070 | United States |
| Background | Behrbohm H. The Dual Character of Nasal Surgery. In: Behrbohm H, Tardy MEJ, eds. Essentials of Septorhinoplasty. Stuttgart, Germany: Thieme; 2004 |
| 6350406 | Background | Geurkink N. Nasal anatomy, physiology, and function. J Allergy Clin Immunol. 1983 Aug;72(2):123-8. doi: 10.1016/0091-6749(83)90518-3. |
| 10837577 | Background | Dahl R, Mygind N. Anatomy, physiology and function of the nasal cavities in health and disease. Adv Drug Deliv Rev. 1998 Jan 5;29(1-2):3-12. doi: 10.1016/s0169-409x(97)00058-6. |
| 7995400 | Background | Rogers DF. Airway goblet cells: responsive and adaptable front-line defenders. Eur Respir J. 1994 Sep;7(9):1690-706. |
| 22473729 | Background | Schroer B, Pien LC. Nonallergic rhinitis: common problem, chronic symptoms. Cleve Clin J Med. 2012 Apr;79(4):285-93. doi: 10.3949/ccjm.79a11099. |
| 21364230 | Background | Greiner AN, Meltzer EO. Overview of the treatment of allergic rhinitis and nonallergic rhinopathy. Proc Am Thorac Soc. 2011 Mar;8(1):121-31. doi: 10.1513/pats.201004-033RN. |
| 25785754 | Background | Halderman A, Sindwani R. Surgical management of vasomotor rhinitis: a systematic review. Am J Rhinol Allergy. 2015 Mar-Apr;29(2):128-34. doi: 10.2500/ajra.2015.29.4141. |
| 6527306 | Background | Kirtane MV, Rajaram D, Merchant SN. Transnasal approach to the vidian nerve: anatomical considerations. J Postgrad Med. 1984 Oct;30(4):210-3. No abstract available. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m2 |
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| rTNSS | The TNSS is an instrument used to collect patient self-rated severity of 4 nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing. Each of the 4 nasal symptoms is rated on a 4-point scale with 0 = no symptoms,1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms. The maximum TNSS is 12 and indicates the most severe symptoms. The "r" in rTNSS indicates a reflective evaluation; in this study, the subject was asked to evaluate symptoms over the preceding 12 hours. | Mean | Standard Deviation | score on a scale |
|
Subjects treated with low power radiofrequency energy applied to the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus) |
|
|
|
| Primary | Percentage of Participants With Treatment Related Adverse Events (Safety) | Characterization of the type and frequency of treatment-related adverse events reported during or following the study procedure. Subjects were asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. Each event was documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. This measure includes any subject who experienced at least one event considered definitely, probably, or possibly related to the device or procedure. | Posted | Count of Participants | Participants | At or following the study procedure, and up to the final study visit at 1 year. |
|
|
|
| Other Pre-specified | rTNSS Responder Rate | The Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. Subjects who showed at least a 1 point improvement (decrease) in the reflective Total Nasal Symptom Score (rTNSS) were categorized as responders. An overall responder rate of at least 55% was expected. | The analyzed population excludes one subject who did not complete the rTNSS questionnaire at the 12 week follow-up visit due to oversight. | Posted | Count of Participants | Participants | Comparison of scores at Baseline and 12 weeks post procedure |
|
|
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| Other Pre-specified | Change in rTNSS Over Time | Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients report their symptoms reflected or felt over the last 12 hours. Total scores range from 0 to 12. A higher score indicates increased symptom severity. The mean change in the rTNSS total score from Baseline to each follow up visit: 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure will be recorded. | 50 subjects were enrolled. 2 week evaluation: 1 subject missed it due to unrelated illness. 4 week evaluation: 1 subject missed it due to travel; 1 other attended the visit but did not complete the questionnaire. 12 week evaluation: All subjects attended but 1 subject did not complete the questionnaire. 26 week evaluation: 2 subjects withdrew from the study prior to the visit. 52 week evaluation: 1 additional subject was lost to follow-up. | Posted | Mean | Standard Deviation | score on a scale | Baseline to each Follow Up Visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. |
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|
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| Other Pre-specified | Change in rTNSS Individual Nasal Symptom Component Scores Over Time | Reflective Total Nasal Symptom Score (rTNSS) is a patient self reported questionnaire of four nasal symptoms: rhinitis, nasal congestion, nasal itching and sneezing. Patients will report their symptoms reflected or felt over the last 12 hours. Total scores can range from 0 to 12. A higher score indicates increased symptom severity. Scores from each of the four components of the questionnaire (rhinorrhea, nasal congestion, nasal itching, and sneezing) will be evaluated at each follow up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. Individual component scores can range from 0 to 3, with a higher score indicating increased symptom severity. | Posted | Mean | Standard Deviation | score on a scale | Baseline to each Follow Up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure |
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|
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| Other Pre-specified | Response on Aerin Quality-of-Life (QOL) Assessment Items | This Quality-of-Life (QOL) instrument is a 9-item patient self-reported questionnaire developed by Aerin Medical to gain understanding of the impact of chronic rhinitis on daily activities, feelings, symptoms and medication use. Each item had 5 possible answers to convey the following responses: very positive, positive, neutral, negative and very negative. Section 1 asks "Please indicate how often you experience the following" for 6 items. For items 1, 3, 4 and 5, those who answered "never/rarely" were considered to have a positive (favorable) response. For questions 2 and 6, those who answered "frequently/very frequently" were considered to have a positive (favorable) response. Section 2 requests "Please indicate how often you use each of the following products to help you with your chronic rhinitis". For 3 items in this section, those who answered "never/rarely" were considered to have a positive (favorable) response. | The baseline QOL was not completed by 4 subjects enrolled in the study. 12 week evaluation: 2 subjects failed to complete the QOL. 26 week evaluation: 2 subjects withdrew from the study prior to the 26 week visit. 52 week evaluation: 1 additional subject was lost to follow-up at this visit. | Posted | Count of Participants | Participants | The QOL was to be completed by the subject at baseline prior to the treatment procedure, and at the 12 week, 26 week and 52 week visits post procedure. |
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| 0 |
| 50 |
| 2 |
| 50 |
| 31 |
| 50 |
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| acute cholecystitis | Gastrointestinal disorders | Systematic Assessment | unrelated to device or procedure |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Sinusitis | Infections and infestations | Systematic Assessment |
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| Upper respiratory tract infection/common cold | Infections and infestations | Systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal mucosa changes | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Nasal bleeding | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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First publication of study results shall be made in conjunction with the results from all clinical study centers participating in the multicenter study. If results of the multi-center study have not been published in full within 18 months after completion of the study, investigator shall be free to publish results. Investigator agrees to submit all proposed publications to the sponsor at least 60 days prior submission; the company has the right to comment.
| Nasal Congestion |
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| Nasal Itching |
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| Sneezing |
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| Neutral or Negative response |
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| Section 1, Item 2: Good sleep throughout the night |
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| Section 1, Item 3: Feeling fatigued during the day |
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| Section 1, Item 4: Feelings of frustration/restlessness/irritability |
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| Section 1, Item 5: Feelings of embarrassment or self-consciousness |
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| Section 1, Item 6: Having a good sense of overall well-being |
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| Section 2, Item 1: Oral medications |
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| Section 2, Item 2: Nasal sprays |
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| Section 2, Item 3: Nasal breathing strips |
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