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RECRUITING
NCT06085209
PHASE1

Cryospray Therapy for Benign Airway Stenosis

Sponsor: Virginia Commonwealth University

View on ClinicalTrials.gov

Summary

This is a clinical evaluation to assess the effectiveness of cryospray therapy used in addition to current standard of care endoscopic therapies in preventing short term recurrent airway stenosis with a multicentric outcome evaluation. The investigators hypothesize that the addition of SCT to standard endoscopic treatment of benign airway stenosis will result in decreased stenosis recurrence at 6 months as estimated by quantitative radiologic assessment of the stenotic volume.

Official title: Cryospray Therapy for Benign Airway Stenosis: a Pilot Study (Pilot-CRYOSTASIS)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

12

Start Date

2023-10-12

Completion Date

2026-12-30

Last Updated

2025-12-10

Healthy Volunteers

No

Interventions

DEVICE

The truFreeze Spray Cryotherapy

A novel FDA cleared technique that allows for liquid nitrogen (LN2) to be delivered in a metered fashion via a catheter through a flexible bronchoscope.

DEVICE

Ballon dilation

An endoscopic balloon that is inflated with water to pressures between 45 and 131 psi (3-9 atm) using a syringe and pressure manometer.

DEVICE

Radial Incision

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Locations (1)

Virgnia Commonwealth University

Richmond, Virginia, United States