NCT05573919

VivAer: A Correlation Between Symptom Scores and Objective Findings

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Endeavor Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	VivAer Stylus	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.

Timeline

• Start date: 2022-10-07
• Primary completion: 2024-05-01
• Completion: 2024-10-01
• First posted: 2022-10-10
• Last updated: 2024-02-21

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study