Chronic RhinitisNCT03727347
Posterior Nasal Nerve (PNN) Rhinitis Study
A study testing InSeca Stylus in people with Chronic Rhinitis, run by Aerin Medical at 5 sites in United States.
Trial summary
Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis Read more about this study
- Who is it for?
- Ages 22 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Rhinitis
- What is being tested?
- InSeca Stylus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesUnited States
- Study dates
- 16 Oct 2018to 17 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Colorado ENT and Allergy
Colorado Springs, Colorado, 80909
Fort Worth ENT
Fort Worth, Texas, 76109
ENT and Allergy Associates of Texas
McKinney, Texas, 75070
Advanced ENT and Allergy
New Albany, Indiana, 47150
Piedmont ENT Associates
Winston-Salem, North Carolina, 27103
About this study
Official title: Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis
Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis
Read the 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.
- Conditions
- Chronic Rhinitis
- Being tested
- InSeca Stylus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InSeca StylusDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: InSeca Stylus |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: At or following the study procedure, and up to the final study visit at 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start16 Oct 2018
- Primary completion1 Feb 2020
- Study completion17 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Chronic RhinitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All enrolled subjects will be treated with the InSeca Stylus
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- V. Vasu Kakarlapudi, MD, Principal investigator, Advanced ENT and Allergy, New Albany, IN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03727347
- Sponsor's protocol ID
- TP668
- Status last verified
- Sep 2020
- First submitted
- 24 Oct 2018
- Last updated
- 16 Jun 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Quillen DM, Feller DB. Diagnosing rhinitis: allergic vs. nonallergic. Am Fam Physician. 2006 May 1;73(9):1583-90.
PubMed 16719251Wallace 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.
PubMed 18662584Behrbohm H. The Dual Character of Nasal Surgery. In: Behrbohm H, Tardy MEJ, eds. Essentials of Septorhinoplasty. Stuttgart, Germany: Thieme; 2004
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.
PubMed 6350406Dahl 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.
PubMed 10837577Rogers DF. Airway goblet cells: responsive and adaptable front-line defenders. Eur Respir J. 1994 Sep;7(9):1690-706.
PubMed 7995400Schroer B, Pien LC. Nonallergic rhinitis: common problem, chronic symptoms. Cleve Clin J Med. 2012 Apr;79(4):285-93. doi: 10.3949/ccjm.79a11099.
PubMed 22473729Greiner 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.
PubMed 21364230Halderman 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.
PubMed 25785754Kirtane 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.
PubMed 6527306
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Low Power Radiofrequency Energy Applied to the Posterior Nasal Nerve Area for Symptomatic Relief of Chronic Rhinitis
- ClinicalTrials.gov ID
- NCT03727347
- Acronym / sponsor ID
- TP668
- Conditions
- Chronic Rhinitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Aerin MedicalIndustry (pharma, biotech, devices)
- Study start
- 16 Oct 2018 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 17 Sep 2020 (actual)
- First posted
- 1 Nov 2018 (actual)
- Results
- Posted 16 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluation of the Aerin Medical Device used for the treatment of chronic rhinitis
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled subjects will be treated with the InSeca Stylus
| Arm | Type | Receives |
|---|---|---|
| InSeca Stylus Treatment Group | Experimental | Device: InSeca StylusSubjects 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) |
Who may qualify
- Ages
- 22 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InSeca StylusLow 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). | Device | InSeca Stylus Treatment Group |
Primary outcome
Change in Reflective Total Nasal Symptom Score (rTNSS)
Time frame: Comparison of scores at Baseline and 12 weeks post procedure
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
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16719251Quillen DM, Feller DB. Diagnosing rhinitis: allergic vs. nonallergic. Am Fam Physician. 2006 May 1;73(9):1583-90.
- Background: PubMed 18662584Wallace 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.
- BackgroundBehrbohm H. The Dual Character of Nasal Surgery. In: Behrbohm H, Tardy MEJ, eds. Essentials of Septorhinoplasty. Stuttgart, Germany: Thieme; 2004
- Background: PubMed 6350406Geurkink N. Nasal anatomy, physiology, and function. J Allergy Clin Immunol. 1983 Aug;72(2):123-8. doi: 10.1016/0091-6749(83)90518-3.
- Background: PubMed 10837577Dahl 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.
- Background: PubMed 7995400Rogers DF. Airway goblet cells: responsive and adaptable front-line defenders. Eur Respir J. 1994 Sep;7(9):1690-706.
- Background: PubMed 22473729Schroer B, Pien LC. Nonallergic rhinitis: common problem, chronic symptoms. Cleve Clin J Med. 2012 Apr;79(4):285-93. doi: 10.3949/ccjm.79a11099.
- Background: PubMed 21364230Greiner 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.
- Background: PubMed 25785754Halderman 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.
- Background: PubMed 6527306Kirtane 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
V. Vasu Kakarlapudi, MD principal investigator
Advanced ENT and Allergy, New Albany, IN
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InSeca Stylus in people with Chronic Rhinitis, run by Aerin Medical at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Reflective Total Nasal Symptom Score (rTNSS) (time frame: Comparison of scores at Baseline and 12 weeks post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03727347, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2021.