NCT06761170 Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)
| NCT ID | NCT06761170 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Beth Israel Deaconess Medical Center |
| Condition | Stenosis of Trachea |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-06-02 |
| Primary Completion | 2027-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 50 participants in total. It began in 2025-06-02 with a primary completion date of 2027-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis. The main question\[s\] investigators aim to answer are: 1. What is the need for reintervention and time to reintervention in participants with benign airway stenosis with simple stenosis who receive spray cryotherapy plus balloon dilatation versus standard of care alone? 2. To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone. Researchers will compare spray cryotherapy plus balloon dilatation versus current standard of Care (SoC - steroid injection, radial cuts and balloon dilatation) in patients with benign airway stenosis with simple stenosis to see if it reduces the need of re intervention. Participants will surgery and receive one of the two interventions.
Eligibility Criteria
Inclusion Criteria: * 1\. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space. * 2\. Stenotic airway of diameter \< 1cm. Exclusion Criteria: 1. Complex stenosis, cartilage involvement (malacia or fracture). 2. Patients with giant bullae (\> a third of hemithorax) or bullae \>3cm. 3. Concurrent tracheoesophageal fistula, active tracheal malignancy. 4. Presence of concomitant upper airway obstruction. 5. Pregnancy
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06761170 clinical trial?
This trial is open to participants of all sexes, studying Stenosis of Trachea. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06761170 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06761170 currently recruiting?
Yes, NCT06761170 is actively recruiting participants. Contact the research team at Cconley@bidmc.harvard.edu for enrollment information.
Where is the NCT06761170 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06761170 clinical trial?
NCT06761170 is sponsored by Beth Israel Deaconess Medical Center. The trial plans to enroll 50 participants.