RECRUITING

VivAer: A Correlation Between Symptom Scores and Objective Findings

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

VivAer: A Correlation Between Symptom Scores and Objective Findings

Quick Facts

Study Start:2022-10-07
Study Completion:2024-10
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05573919

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Adults 18 years and older seeking treatment for nasal obstruction and willing to undergo an office-based procedure.
  2. * Nasal obstruction, defined as ≥60 by the NOSE scale.
  3. * 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.
  4. * 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).
  5. * Subject experienced minimal symptomatic improvement after the four-week fluticasone steroid nasal spray regimen.
  1. * Prior surgery to the nasal valve, rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past 12 months.
  2. * Severe and/or chronic sinusitis, recurrent sinusitis, or allergies leading to nasal obstruction and currently requiring oral corticosteroid therapy.
  3. * 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.
  4. * Known or suspected allergies or contraindications to the anesthetic agents and/or antibiotic medications to be used during the study procedure session.
  5. * Known or suspected pregnancy, or lactation.
  6. * Other medical conditions that the investigator believed would predispose subject to poor wound healing or increased surgical risk.

Contacts and Locations

Study Contact

Riley J Medenwald, BS
CONTACT
874-570-3944
RMedenwald@northshore.org

Principal Investigator

Auddie Sweis, MD
PRINCIPAL_INVESTIGATOR
NorthShore University HealthSystem
Joseph Raviv, MD
PRINCIPAL_INVESTIGATOR
NorthShore University HealthSystem

Study Locations (Sites)

Swedish Covenant Hospital
Chicago, Illinois, 60625
United States
NorthShore Skokie Hospital
Skokie, Illinois, 60076
United States

Collaborators and Investigators

Sponsor: NorthShore University HealthSystem

  • Auddie Sweis, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem
  • Joseph Raviv, MD, PRINCIPAL_INVESTIGATOR, NorthShore University HealthSystem

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-07
Study Completion Date2024-10

Study Record Updates

Study Start Date2022-10-07
Study Completion Date2024-10

Terms related to this study

Keywords Provided by Researchers

  • VivAer
  • Symptom Improvement

Additional Relevant MeSH Terms

  • Nasal Obstruction
  • Medically Unexplained Symptoms
  • Airway Obstruction
  • Airway Remodeling