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Cryospray Therapy for Benign Airway Stenosis

Study acronym: CRYOSTASIS
StatusRecruiting
PhasePhase 1
Started
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Record History

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  1. Primary and study completion dates: Sep 30, 2025 to Dec 30, 2026v5
  2. Primary and study completion dates: Sep 2025 to Sep 30, 2025v4
  3. Start date changed from estimate of Oct 30, 2023 to Oct 12, 2023v3
  4. Secondary endpoints revised (3)
    • Site contact updated
    • Study title shortened, about 4 words
    v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06085209
Lead Sponsor Virginia Commonwealth University
Collaborators: US Endoscopy Group Inc.
Conditions
(from sponsor)		 Stenosis Trachea
Related terms Tracheal Stenosis
Enrollment 12 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov