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Posterior Nasal Nerve (PNN) Rhinitis Study

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ClinicalTrials.gov Identifier: NCT03727347
Recruitment Status : Active, not recruiting
First Posted : November 1, 2018
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Aerin Medical

Brief Summary:
Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis

Condition or disease Intervention/treatment Phase
Chronic Rhinitis Device: InSeca Stylus Not Applicable

Detailed Description:
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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All enrolled subjects will be treated with the InSeca Stylus
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis
Actual Study Start Date : October 16, 2018
Estimated Primary Completion Date : February 1, 2020
Estimated Study Completion Date : February 1, 2020

Arm Intervention/treatment
Experimental: 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)
Device: InSeca Stylus
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).




Primary Outcome Measures :
  1. Reflective Total Nasal Symptom Score (rTNSS) [ Time Frame: Baseline to 12 weeks post procedure ]
    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

  2. Percentage of Participants with Treatment Related Adverse Events (Safety) [ Time Frame: At or following the study procedure, and up to the final study visit at 1 year. ]
    Characterizing the type and frequency of adverse events reported. Subjects will be asked about possible side effects or adverse experiences related to the study procedure at each follow up visit. All events will be documented and identified as to its relationship and level of relatedness to the study device and/or study procedure. Date of onset, severity, duration and outcome will be documented.


Other Outcome Measures:
  1. Responder Rate [ Time Frame: Baseline compared to 12 weeks post procedure ]
    At least a 1 point improvement (decrease) in the rTNSS score. An overall responder rate of at least 55% is expected.

  2. rTNSS Over Time [ Time Frame: Baseline to each Follow Up Visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. ]
    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 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.

  3. rTNSS Individual Nasal Symptom Scores [ Time Frame: Baseline to each Follow Up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure ]
    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. Individual patient scores will be evaluated at each follow up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure. Scores of each question will be summarized.

  4. Quality-of-Life (QOL) Questionnaire [ Time Frame: The QOL will be completed by the subject both prior to the treatment procedure, and at the 12 week, 26 week and 52 week visits post procedure. ]
    Quality-of-Life (QOL) is a patient self reported questionnaire that will be used to gain understanding of the impact of chronic rhinitis on daily activities, feelings, symptoms and medication use. The answers use a 5-point Likert scale and range from Very Rarely to Very Frequently. Scores that are higher reflect worse rhinitis related quality-of-life. The QOL will be completed by the subject both prior to the treatment procedure, and at the 12 week, 26 week and 52 week follow-up visits post procedure. Response for each question will be summarized.

  5. Subject Satisfaction Survey [ Time Frame: The Subject Satisfaction Survey will be completed by the subject at the 12 week and 52 week visit post procedure ]
    Subject Satisfaction Survey is a patient self reported questionnaire to assess patient acceptance of the treatment procedure and results. 5 questions are asked on a 10-point scale where a score of 1 is a poor acceptance of the procedure and 10 is a positive acceptance. Subjects will be asked to complete the Subject Satisfaction Survey at the 12-week and 52-week follow-up visits post procedure

  6. Nasal Status Assessment [ Time Frame: Baseline, 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure ]
    The Nasal Status Assessment is an evaluation, performed by a physician, of 10 specified physical or intranasal findings. Each finding is ranked in severity from Not Present to Severe. Each component of the assessment will be summarized.

  7. Visual Analog Scale (VAS) for Pain [ Time Frame: The VAS Pain will be completed by the subjects at the 2 week, 4 week, 12 week visit post procedure ]
    The Visual Analog Scale (VAS) is a self reported score of pain felt during the treatment session and pain as it exists at specified visits post procedure. Patients will mark where they feel their pain exists on a 10 cm line. A score of 0 = No Pain and a score of 10 = Worst Pain Imaginable. Pain scores will be summarized for pain reported immediately post procedure and at the 2 week, 4 week and 12 week visit post procedure.

  8. Concomitant Medication Usage [ Time Frame: Baseline, 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks visit post procedure ]
    Patients will report any medication they are using at each study visit. Medication information will be summarized and reviewed to understand type, dose, frequency, duration and relation.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Age 22 to 75 years (inclusively)
  2. Willing and able to provide informed consent
  3. Willing and able to comply with the subject-specific requirements outlined in the study protocol
  4. Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure
  5. Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea)
  6. Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion)
  7. rTNSS score of greater than or equal to 6
  8. Dissatisfaction with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief, as judged by the subject

Exclusion Criteria:

  1. Anatomic obstructions that in the investigator's opinion limit access to the posterior nose
  2. Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury
  3. Active nasal or sinus infection
  4. Moderate to severe ocular allergic symptoms (such as eye tearing [epiphora], itching [pruritus], or redness [erythema])
  5. History of significant dry eye
  6. History of any of the following: nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation
  7. Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session
  8. Known or suspected to be pregnant, or is lactating
  9. Participating in another clinical research study
  10. Other medical conditions which in the opinion of the investigator would predispose the subject to poor wound healing, increased surgical risk, or poor compliance with the requirements of the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727347


Locations
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United States, Colorado
Colorado ENT and Allergy
Colorado Springs, Colorado, United States, 80909
United States, Indiana
Advanced ENT and Allergy
New Albany, Indiana, United States, 47150
United States, North Carolina
Piedmont ENT Associates
Winston-Salem, North Carolina, United States, 27103
United States, Texas
Fort Worth ENT
Fort Worth, Texas, United States, 76109
ENT and Allergy Associates of Texas
McKinney, Texas, United States, 75070
Sponsors and Collaborators
Aerin Medical

Publications:
Behrbohm H. The Dual Character of Nasal Surgery. In: Behrbohm H, Tardy MEJ, eds. Essentials of Septorhinoplasty. Stuttgart, Germany: Thieme; 2004

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Responsible Party: Aerin Medical
ClinicalTrials.gov Identifier: NCT03727347     History of Changes
Other Study ID Numbers: TP668
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases