Cryospray Therapy for Benign Airway Stenosis

Conditions

• Stenosis Trachea

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• The truFreeze Spray Cryotherapy — DEVICE
  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.
• Ballon dilation — DEVICE
  An endoscopic balloon that is inflated with water to pressures between 45 and 131 psi (3-9 atm) using a syringe and pressure manometer.
• Radial Incision — DEVICE
  Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Study Details

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.

Key Dates

Start date

Oct 12, 2023

Status verified

Dec 2025

Primary completion

Dec 30, 2026

Completion

Dec 30, 2026

Study Design

Enrollment

12 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Intervention
  Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy
• Active Comparator: Standard of care
  Bronchoscopic balloon dilation with radial cuts

Primary Outcome Measure

Degree of re-stenosis [ Time Frame: 6 months ]

Central Contacts

• Ramsha Hamid
  (804) 628-2176
  [email protected]

Locations (1)

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