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NCT06085209 · ClinicalTrials.gov registry record · Phase 1
Cryospray Therapy for Benign Airway Stenosis
A Phase 1 study of Stenosis Trachea, sponsored by Virginia Commonwealth University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT06085209: Recruiting Phase 1 study of Stenosis Trachea, sponsored by Virginia Commonwealth University.
NCT06085209 is a Phase 1 study of Stenosis Trachea that is actively recruiting participants, run by Virginia Commonwealth University. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06085209, a Phase 1 study of Stenosis Trachea, is actively recruiting participants, sponsored by Virginia Commonwealth University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
The degree of re-stenosis at 6 months expressed as the percentage of airway lumen volume within the stenotic segment at 6 months compared to personal best patency volume on CT scan performed within five weeks of the study intervention.
Conditions Studied
Interventions
- DEVICE The truFreeze Spray Cryotherapy
- DEVICE Ballon dilation
- DEVICE Radial Incision
Study Locations (1)
Virginia
- Virgnia Commonwealth University - Richmond
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-10-12 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 1 |
What NCT06085209 shows while recruiting
NCT06085209 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 1 condition, with Stenosis Trachea appearing as the primary indexed condition, and to 3 interventions - of which The truFreeze Spray Cryotherapy is the first listed.
NCT06085209 reports a single indexed study location in Virginia.
Frequently Asked Questions
What is clinical trial NCT06085209 about?
NCT06085209 is a clinical study titled "Cryospray Therapy for Benign Airway Stenosis". 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 standa...
What is the current status of trial NCT06085209?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2023-10-12. Estimated completion is 2026-12-30.
What conditions does trial NCT06085209 study?
This clinical trial studies the following conditions: Stenosis Trachea.
What interventions are being tested in trial NCT06085209?
The interventions under investigation include: The truFreeze Spray Cryotherapy (DEVICE), Ballon dilation (DEVICE), Radial Incision (DEVICE).
Who is sponsoring clinical trial NCT06085209?
This trial is sponsored by Virginia Commonwealth University, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06085209 being conducted?
This trial has 1 study location across Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06085209's enrollment target sits among peer trials
12 1853rd of 2000 higher than 90 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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