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VivAer: A Correlation Between Symptom Scores and Objective Findings

Primary Purpose

Nasal Obstruction, Medically Unexplained Symptoms, Airway Obstruction

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

VivAer Stylus

About this trial

This is an interventional treatment trial for Nasal Obstruction focused on measuring VivAer, Symptom Improvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
Nasal obstruction, defined as ≥60 by the NOSE scale.
The nasal valve is the primary or significant contributor to the subject's nasal obstruction as determined by the investigator, based on clinical presentation, physical examination, or nasal endoscopy.
Subjects has symptomatic improvement with use of external or internal nasal dilators, Q-Tip or curette test (manual intranasal lateralization), or the Cottle Maneuver (manual lateral retraction of the cheek).
Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen.

Exclusion Criteria:

Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past 12 months.
Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy.
Severe case of any of the following; septal deviation, turbinate hypertrophy, polyps, or ptotic nasal tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention.
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 pregnancy, or lactation.
Other medical conditions that the investigator believed would predispose subject to poor wound healing or increased surgical risk.

Sites / Locations

Swedish Covenant HospitalRecruiting
NorthShore Skokie HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

VivAer Patients

Arm Description

These patients will undergo the VivAer procedure, which involves the use of a stylus to deliver radiofrequency heating to the nasal sidewall to reshape the tissue. This will be done to resolve the patients' nasal obstruction. They will have PNIF measurements taken and will complete symptom assessment questionnaires before and after the VivAer procedure.

Outcomes

Primary Outcome Measures

PNIF Measurement

The change in the severity of the patients' nasal obstruction will be measured using a Peak Nasal Inspiratory Flow (PNIF) meter. This meter measures nasal patency by measuring the volume of air that is inhaled per minute during normal breathing.

Secondary Outcome Measures

NOSE Score

The patients will self-assess the degree of their symptoms with the Nasal Obstructive Symptom Evaluation (NOSE) questionnaire. The questionnaire consists of 5 questions ranking the severity of one's symptoms on a scale of 0-5. The responses are summed and multiplied by 20 to generate a symptom score out of 0-100. Higher scores indicate worse outcomes.

SNOT-22 Score

The patients will self-assess the degree of their symptoms with the SinoNasal Outcome Test (SNOT-22) questionnaire. The questionnaire consists of 22 questions ranking the impact of a patient's symptoms on their quality of life on a scale of 0-5. The responses are summed to generate a score out of 110. Higher scores indicate worse outcomes.

Full Information

NCT ID

NCT05573919

First Posted

October 4, 2022

Last Updated

December 4, 2022

Sponsor

NorthShore University HealthSystem

1. Study Identification

Unique Protocol Identification Number

NCT05573919

Brief Title

VivAer: A Correlation Between Symptom Scores and Objective Findings

Official Title

VivAer: A Correlation Between Symptom Scores and Objective Findings

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Recruiting

Study Start Date

October 7, 2022 (Actual)

Primary Completion Date

May 2024 (Anticipated)

Study Completion Date

October 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

NorthShore University HealthSystem

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief Summary

This is a prospective, single-center study. This study seeks to determine the objective improvement in nasal airflow in patients after undergoing the VivAer procedure, which involves the use of a stylus to deliver controlled and targeted low energy radiofrequency heating (heating by applying high-frequency radio waves) to the nasal sidewall to gently reshape the tissues. Patients who experience refractory, or medically unexplained, nasal obstruction often have symptoms that are not alleviated or resolved by standard non-surgical treatment options. VivAer, a recently developed, FDA-approved procedure, is one of the standard surgical treatments for nasal obstruction. Unlike most of the other established surgical treatments for nasal obstruction, however, VivAer is a minimally-invasive procedure, and it is an outpatient intervention that can be performed under local anesthetic. Eligible patients who are enrolled in the study will undergo the VivAer procedure, and will return to the clinic for three in-office follow-up visits at 4, 12, and 24 weeks after the procedure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Obstruction, Medically Unexplained Symptoms, Airway Obstruction, Airway Remodeling

Keywords

VivAer, Symptom Improvement

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

Patients who are to undergo the VivAer procedure for nasal obstruction with Dr. Auddie Sweis or Dr. Joseph Raviv will be recruited to this study. They will be issued questionnaires and have PNIF measurements taken to assess their symptoms before and after the procedure in order to determine the objective improvement in the patients' symptoms.

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

VivAer Patients

Arm Type

Experimental

Arm Description

Intervention Type

Device

Intervention Name(s)

VivAer Stylus

Intervention Description

This device will be used to complete its corresponding procedure, which involves reshaping a patient's nasal sidewall tissue through the delivery of radiofrequency heating.

Primary Outcome Measure Information:

Title

PNIF Measurement

Description

Time Frame

This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.

Secondary Outcome Measure Information:

Title

NOSE Score

Description

Time Frame

This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.

Title

SNOT-22 Score

Description

Time Frame

This will be administered before the VivAer procedure and at 4, 12, and 24 weeks post procedure.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an office-based procedure. Nasal obstruction, defined as ≥60 by the NOSE scale. The nasal valve is the primary or significant contributor to the subject's nasal obstruction as determined by the investigator, based on clinical presentation, physical examination, or nasal endoscopy. Subjects has symptomatic improvement with use of external or internal nasal dilators, Q-Tip or curette test (manual intranasal lateralization), or the Cottle Maneuver (manual lateral retraction of the cheek). Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen. Exclusion Criteria: Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past 12 months. Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy. Severe case of any of the following; septal deviation, turbinate hypertrophy, polyps, or ptotic nasal tip believed to be the primary contributor to the subject's nasal obstruction symptoms and warranting surgical intervention. 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 pregnancy, or lactation. Other medical conditions that the investigator believed would predispose subject to poor wound healing or increased surgical risk.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Riley J Medenwald, BS

Phone

874-570-3944

RMedenwald@northshore.org

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Auddie Sweis, MD

Organizational Affiliation

NorthShore University HealthSystem

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joseph Raviv, MD

Organizational Affiliation

NorthShore University HealthSystem

Official's Role

Principal Investigator

Facility Information:

Facility Name

Swedish Covenant Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60625

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Auddie Sweis, MD

ASweis@northshore.org

First Name & Middle Initial & Last Name & Degree

Auddie Sweis, MD

Facility Name

NorthShore Skokie Hospital

City

Skokie

State/Province

Illinois

ZIP/Postal Code

60076

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Auddie Sweis, MD

ASweis@northshore.org

First Name & Middle Initial & Last Name & Degree

Auddie Sweis, MD

First Name & Middle Initial & Last Name & Degree

Joseph Raviv, MD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31024989

Citation

Jacobowitz O, Driver M, Ephrat M. In-office treatment of nasal valve obstruction using a novel, bipolar radiofrequency device. Laryngoscope Investig Otolaryngol. 2019 Feb 4;4(2):211-217. doi: 10.1002/lio2.247. eCollection 2019 Apr.

Results Reference

background

PubMed Identifier

32810380

Citation

Ephrat M, Jacobowitz O, Driver M. Quality-of-life impact after in-office treatment of nasal valve obstruction with a radiofrequency device: 2-year results from a multicenter, prospective clinical trial. Int Forum Allergy Rhinol. 2021 Apr;11(4):755-765. doi: 10.1002/alr.22667. Epub 2020 Aug 9.

Results Reference

background

PubMed Identifier

15054368

Citation

Stewart MG, Smith TL, Weaver EM, Witsell DL, Yueh B, Hannley MT, Johnson JT. Outcomes after nasal septoplasty: results from the Nasal Obstruction Septoplasty Effectiveness (NOSE) study. Otolaryngol Head Neck Surg. 2004 Mar;130(3):283-90. doi: 10.1016/j.otohns.2003.12.004.

Results Reference

background

PubMed Identifier

23846399

Citation

Lipan MJ, Most SP. Development of a severity classification system for subjective nasal obstruction. JAMA Facial Plast Surg. 2013 Sep-Oct;15(5):358-61. doi: 10.1001/jamafacial.2013.344.

Results Reference

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VivAer: A Correlation Between Symptom Scores and Objective Findings

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