Stenosis of TracheaPhase 2Cryo-BASNCT06761170
Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)
A Phase 2 study testing Spray cryo therapy in people with Stenosis of Trachea, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stenosis of Trachea
- What is being tested?
- Spray cryo therapy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to 15 Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
- 2. Stenotic airway of diameter < 1cm.
Who cannot join
- Complex stenosis, cartilage involvement (malacia or fracture).
- Patients with giant bullae (> a third of hemithorax) or bullae >3cm.
- Concurrent tracheoesophageal fistula, active tracheal malignancy.
- Presence of concomitant upper airway obstruction.
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Adnan Majid, MD, 617-632-8252, amajid@bidmc.harvard.edu
Christine Conley, Healthcare Administration, 6176328386, cconley@bidmc.harvard.edu
About this study
Official title: Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial
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:
- 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?
- To evaluate patient experience, physiological, anatomical changes, health care utilization and safety of the SCT plus balloon dilatation versus standard of care alone.
Read more
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.
Read the detailed description
Investigators propose a single center, single-blinded (patient), randomized 1:1 trial comparing SCT plus Balloon dilatation (experimental group) vs SoC alone (control group). Investigators aim to recruit 50 patients.
Study will span 2-year duration with 1 year recruitment. Follow up at 6 weeks, 3 months, 6 months, 12 months. The patient's airway will be either a laryngeal mask airway or a rigid bronchoscopy for passive venting and gas egress.
- Conditions
- Stenosis of Trachea
- Being tested
- Spray cryo therapy, Standard of Care (SOC)
- Keywords
- Stenosis of trachea, benign, spray cryotherapy
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spray cryo therapyProcedure or surgery
normal flow, 5 seconds repeated for 3-5 cycles
Standard of Care (SOC)Procedure or surgery
- Steroid injection
- Radial mucosal incision
- Balloon dilation (to normal airway diameter)
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Experimental | 1. Stenotic lumen diameter > 8mm:
1. Spray Cryo Therapy for 5s, repeated 3-5 cycles
2. Balloon dilation (to normal airway diameter)
2. Stenotic lumen diameter < 8mm
1. Balloon dilation (up to 8mm diameter)
2. Spray Cryo Therapy for 5s, repeated 3-5 cycles 3) Balloon dilation (to normal airway diameter) Receives: Procedure: Spray cryo therapy |
| Control | Active comparator | 1. Steroid injection
2. Radial mucosal incision
3. Balloon dilation (to normal airway diameter) Receives: Procedure: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need of re intervention
Number of patients that require new intervention for the benign airway stenosis.
Measured: Need of re intervention in two years
Secondary outcomes (1)
Time to re intervention
Time it takes in days for a patient to need a re intervention for the benign airway stenosis after treatment.
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2025
- Study start2 Jun 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stenosis of TracheaStudies of the same condition, open and under way.
- More trials run by Beth Israel Deaconess Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- American Association of Broncology and Interventional Pulmonology
- Responsible party
- Principal investigator, Adnan Majid, MD, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06761170
- Sponsor's protocol ID
- 2024P000875
- Acronym
- Cryo-BAS
- Status last verified
- Jul 2025
- First submitted
- 23 Dec 2024
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Leong P, Bardin PG, Lau KK. What's in a name? Expiratory tracheal narrowing in adults explained. Clin Radiol. 2013 Dec;68(12):1268-75. doi: 10.1016/j.crad.2013.06.017. Epub 2013 Aug 13.
PubMed 23953005
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06761170
- Acronym / sponsor ID
- Cryo-BAS / 2024P000875
- Conditions
- Stenosis of Trachea
- Keywords
- Stenosis of trachea, benign, spray cryotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- American Association of Broncology and Interventional Pulmonology
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jan 2027 (estimated)
- First posted
- 7 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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?
- 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.
Detailed description
Investigators propose a single center, single-blinded (patient), randomized 1:1 trial comparing SCT plus Balloon dilatation (experimental group) vs SoC alone (control group). Investigators aim to recruit 50 patients.
Study will span 2-year duration with 1 year recruitment. Follow up at 6 weeks, 3 months, 6 months, 12 months. The patient's airway will be either a laryngeal mask airway or a rigid bronchoscopy for passive venting and gas egress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional | Experimental | Procedure: Spray cryo therapy1. Stenotic lumen diameter > 8mm: 1. Spray Cryo Therapy for 5s, repeated 3-5 cycles 2. Balloon dilation (to normal airway diameter) 2. Stenotic lumen diameter < 8mm 1. Balloon dilation (up to 8mm diameter) 2. Spray Cryo Therapy for 5s, repeated 3-5 cycles 3) Balloon dilation (to normal airway diameter) |
| Control | Active comparator | Procedure: Standard of Care (SOC)1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 1. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
- 2. Stenotic airway of diameter < 1cm.
Key exclusion criteria (5 listed)
- Complex stenosis, cartilage involvement (malacia or fracture).
- Patients with giant bullae (> a third of hemithorax) or bullae >3cm.
- Concurrent tracheoesophageal fistula, active tracheal malignancy.
- Presence of concomitant upper airway obstruction.
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spray cryo therapynormal flow, 5 seconds repeated for 3-5 cycles | Procedure or surgery | Interventional |
| Standard of Care (SOC)1. Steroid injection 2. Radial mucosal incision 3. Balloon dilation (to normal airway diameter) | Procedure or surgery | Control |
Primary outcome
Need of re intervention
Time frame: Need of re intervention in two years
Number of patients that require new intervention for the benign airway stenosis.
1 secondary outcome
Time to re intervention
Time frame: Two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Background: PubMed 23953005Leong P, Bardin PG, Lau KK. What's in a name? Expiratory tracheal narrowing in adults explained. Clin Radiol. 2013 Dec;68(12):1268-75. doi: 10.1016/j.crad.2013.06.017. Epub 2013 Aug 13.
- Individual participant dataSharing planned: No
Related trials for Stenosis of Trachea
Not yet recruitingPhase 1
Pirfenidone for Idiopathic Subglottic Stenosis: A Pilot Trial of Tolerability and Feasibility
Idiopathic Subglottic Stenosis, Subglottic Stenosis (SGS)
Not yet recruitingObservational study
Laryngotracheal Lesions in Adults With Long-Term Tracheostomy
Laryngotracheal Lesions, Tracheostomy Complications
RecruitingPhase 3
Adjuvant Steroid Outcomes in Idiopathic Subglottic Stenosis
Idiopathic Subglottic Stenosis
Recruiting
Transcriptomic Profile Changes in Benign Tracheal Stenosis: Wedge Resection vs. Radial Incision
Tracheal Stenosis
Enrolling by invitation
Feasibility of Tracheobronchial Reconstruction Using Allogenic Aortic Patch in Children
Trachea Diseases, Tracheal Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Spray cryo therapy in people with Stenosis of Trachea, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Conley (617-632-8386, Cconley@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Need of re intervention (time frame: Need of re intervention in two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06761170, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.