Posterior Nasal Nerve (PNN) Rhinitis Study

NCT03727347 | Completed Results FDA Device

• 1 other identifier: TP668
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 5

Brief Summary

Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis

Conditions

Chronic Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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.

Other Outcomes (4)

• rTNSS Responder Rate

  Comparison of scores at Baseline and 12 weeks post procedure

• Change in rTNSS Over Time

  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

  Baseline to each Follow Up visit at 2 weeks, 4 weeks, 12 weeks, 26 weeks and 52 weeks post procedure

Study Arms (1)

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)

Device: InSeca Stylus

Interventions

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).

InSeca Stylus Treatment Group

Eligibility Criteria

• Age: 22 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 22 to 75 years (inclusively)
• Willing and able to provide informed consent
• Willing and able to comply with the subject-specific requirements outlined in the study protocol
• Seeking treatment for chronic rhinitis symptoms of at least 6 months duration and willing to undergo an office-based procedure
• Moderate to severe symptoms of rhinorrhea (rTNSS rating of 2 or 3 for rhinorrhea)
• Mild to severe symptoms of nasal congestion (rTNSS rating of 1, 2 or 3 for congestion)
• rTNSS score of greater than or equal to 6
• 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

You may not qualify if:

• Anatomic obstructions that in the investigator's opinion limit access to the posterior nose
• Altered anatomy of the posterior nose as a result of prior sinus or nasal surgery or injury
• Active nasal or sinus infection
• Moderate to severe ocular allergic symptoms (such as eye tearing \[epiphora\], itching \[pruritus\], or redness \[erythema\])
• History of significant dry eye
• History of any of the following: nose bleeds in the past 3 months, rhinitis medicamentosa, head or neck irradiation
• Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session
• Known or suspected to be pregnant, or is lactating
• Participating in another clinical research study
• 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

Sponsors & Collaborators

• Aerin Medical: lead

Study Sites (5)

Colorado ENT and Allergy

Colorado Springs, Colorado, 80909, United States

Location

Advanced ENT and Allergy

New Albany, Indiana, 47150, United States

Location

Piedmont ENT Associates

Winston-Salem, North Carolina, 27103, United States

Location

Fort Worth ENT

Fort Worth, Texas, 76109, United States

Location

ENT and Allergy Associates of Texas

McKinney, Texas, 75070, United States

Location

Related Publications (10)

• Quillen DM, Feller DB. Diagnosing rhinitis: allergic vs. nonallergic. Am Fam Physician. 2006 May 1;73(9):1583-90.

  PMID: 16719251 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.

  PMID: 18662584 BACKGROUND

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

  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.

  PMID: 6350406 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.

  PMID: 10837577 BACKGROUND

• Rogers DF. Airway goblet cells: responsive and adaptable front-line defenders. Eur Respir J. 1994 Sep;7(9):1690-706.

  PMID: 7995400 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.

  PMID: 22473729 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.

  PMID: 21364230 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.

  PMID: 25785754 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.

  PMID: 6527306 BACKGROUND

Results Point of Contact

• Title: Anais Laborde
• Organization: Aerin Medical, Inc.

alaborde@aerinmedical.com

(650) 518-9624

Study Officials

• V. Vasu Kakarlapudi, MD

  Advanced ENT and Allergy, New Albany, IN

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: All enrolled subjects will be treated with the InSeca Stylus

Study Record Dates

• First Submitted: October 24, 2018
• First Posted: November 1, 2018
• Study Start: October 16, 2018
• Primary Completion: February 1, 2020
• Study Completion: September 17, 2020
• Last Updated: June 16, 2021
• Results First Posted: June 16, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)