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Cryospray Therapy for Benign Airway Stenosis

NCT06085209 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-12-10

No results posted yet for this study

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.

Conditions

  • Stenosis Trachea

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

Sponsors & Collaborators

  • US Endoscopy Group Inc.

    collaborator INDUSTRY

  • Virginia Commonwealth University

    lead OTHER

Principal Investigators

  • Ray Shepherd · Virginia Commonwealth University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-12
Primary Completion
2026-12-30
Completion
2026-12-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06085209 on ClinicalTrials.gov