Stenosis TracheaPhase 1CRYOSTASISNCT06085209
Cryospray Therapy for Benign Airway Stenosis
A Phase 1 study testing The truFreeze Spray Cryotherapy, Ballon dilation and Radial Incision in people with Stenosis Trachea, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stenosis Trachea
- What is being tested?
- The truFreeze Spray Cryotherapy, Ballon dilation and Radial Incision
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2023to 30 Dec 2026
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referral to interventional pulmonology or otorhinolaryngology or thoracic surgery for endoscopic management of suspected benign tracheal stenosis.
- Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or previous bronchoscopy
- Able to provide informed consent.
- Age > 18
Who cannot join
- Inability to provide informed consent
- Pregnancy
- Known or suspected malignant central airway stenosis
- Patient has already been enrolled in this study.
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
Show all 17Show fewer
- Pneumothorax in the previous 12 months
- Severe COPD (defined as a FEV1/FVC < 70% and FEV1 <30% predicted) and/or severe persistent asthma.
- Hemodynamic instability with systolic blood pressure <90 mmHg or heart rate > 120 beats/min, unless deemed to be stable with these values by the attending physicians.
- Compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs.
- Significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. PEG tube)
- Significantly reduced elasticity of the ablation area (e.g. Marfan's Syndrome)
- Prior complications with SCT (Spray cryotherapy)
- Contraindication to rigid bronchoscopy
- Significant tracheomalacia or alterations in cartilage integrity on CT (Computed Tomography) that would require stent placement or surgical referral.
- Greater than 1 BCAS intervention, excluding cricotracheal (tracheal surgery) resection, within 6 months before enrollment.
- Anatomical flow resistance (gas evacuation) where any procedure or anatomy proximal to the ablation site has significantly reduced or restricted the flow area of the lumen creating restriction where gas created from liquid nitrogen cannot adequately vent.
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
Virgnia Commonwealth University
Richmond, Virginia, 23298
Ray Shepherd, 804-828-9071, ray.shepherd@vcuhealth.org
Ramsha Hamid, (804) 628-2176, ramsha.hamid@vcuhealth.org
About this study
Official title: Cryospray Therapy for Benign Airway Stenosis: a Pilot Study (Pilot-CRYOSTASIS)
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.
Read the detailed description
Spray cryo treatment of tracheal stenosis has the potential for long-lasting endoscopic management of BCAS and is used as part of routine clinical care by many physicians, but there is a relative paucity of peer-reviewed data, and no randomized controlled trial has been performed. Thus, the study could potentially show that the use of spray cryo therapy could allow patients to undergo fewer procedures to treat this condition, or lengthen the amount of time required in between these procedures, or play a role in the resolution of this condition.
- Conditions
- Stenosis Trachea
- Being tested
- The truFreeze Spray Cryotherapy, Ballon dilation, Radial Incision
- Keywords
- cryospray therapy, benign airway stenosis
- Medical subject headings
- Tracheal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The truFreeze Spray CryotherapyDevice
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 dilationDevice
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 IncisionDevice
Carbon dioxide (CO2) laser or Monopolar electrocautery knife
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy Receives: Device: The truFreeze Spray Cryotherapy; Device: Ballon dilation; Device: Radial Incision |
| Standard of care | Active comparator | Bronchoscopic balloon dilation with radial cuts Receives: Device: Ballon dilation; Device: Radial Incision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of re-stenosis
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.
Measured: 6 months
Secondary outcomes (3)
Change in Peak Expiratory Flow (PEF)
Evidence supports the use of PEF as a simple, efficient, and accessible way of monitoring progression of tracheal stenosis. PEF has previously been captured in clinical encounters as component of the decision-making algorithm for surgical intervention in tracheal stenosis patients. Mobile Device Software 'App' can robustly capture longitudinal patient reported outcome measures. A previously developed mobile device software 'Airflo' for tracking patient-generated health data and has proven the ability to successfully implement this software.
Measured: Continous for 6 months
Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ)
The CCQ has been used as a validated quality of life measure in laryngotracheal stenosis. The investigators will send surveys out to patients at set time intervals to assess symptom improvement pre- and post-intervention. The questions are divided into three areas or domains. Symptoms 1, 2, 5, 6; Functional state 7, 8, 9, 10; Mental state 3 and 4. All items are equally weighted by adding score of ten items and dividing by the number ten. The score varies between 0 (very good health status) to 6 (extremely poor health status).
Measured: 2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,
Incidence of complications between groups
Incidence of complications (hypoxemia, bleeding, pneumothorax rate, barotrauma).
Measured: Continous for 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study start12 Oct 2023
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stenosis TracheaStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated in a 1:1 fashion to intervention standard of care (SOC) + SCT and control (SOC) groups. Participants will be blinded to the use of SCT to prevent knowledge of their group assignment from biasing their subjective assessments. Adjudicators in the primary outcome measurements (quantitative CT) will be blinded to group assignment as well.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Collaborators
- US Endoscopy Group Inc.
- Responsible party
- Sponsor
- Investigators
- Ray Shepherd, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085209
- Sponsor's protocol ID
- HM20027230
- Acronym
- CRYOSTASIS
- Status last verified
- Dec 2025
- First submitted
- 28 Sep 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryospray Therapy for Benign Airway Stenosis: a Pilot Study (Pilot-CRYOSTASIS)
- ClinicalTrials.gov ID
- NCT06085209
- Acronym / sponsor ID
- CRYOSTASIS / HM20027230
- Conditions
- Stenosis Trachea
- Keywords
- cryospray therapy, benign airway stenosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Collaborators
- US Endoscopy Group Inc.
- Study start
- 12 Oct 2023 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 16 Oct 2023 (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.
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.
Detailed description
Spray cryo treatment of tracheal stenosis has the potential for long-lasting endoscopic management of BCAS and is used as part of routine clinical care by many physicians, but there is a relative paucity of peer-reviewed data, and no randomized controlled trial has been performed. Thus, the study could potentially show that the use of spray cryo therapy could allow patients to undergo fewer procedures to treat this condition, or lengthen the amount of time required in between these procedures, or play a role in the resolution of this condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated in a 1:1 fashion to intervention standard of care (SOC) + SCT and control (SOC) groups. Participants will be blinded to the use of SCT to prevent knowledge of their group assignment from biasing their subjective assessments. Adjudicators in the primary outcome measurements (quantitative CT) will be blinded to group assignment as well.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: The truFreeze Spray Cryotherapy, Device: Ballon dilation, Device: Radial IncisionBronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy |
| Standard of care | Active comparator | Device: Ballon dilation, Device: Radial IncisionBronchoscopic balloon dilation with radial cuts |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Referral to interventional pulmonology or otorhinolaryngology or thoracic surgery for endoscopic management of suspected benign tracheal stenosis.
- Significant tracheal stenosis defined by stenosis ≥ 50% of tracheal lumen assessed on chest CT or previous bronchoscopy
- Able to provide informed consent.
- Age > 18
Key exclusion criteria (17 listed)
- Inability to provide informed consent
- Pregnancy
- Known or suspected malignant central airway stenosis
- Patient has already been enrolled in this study.
- Study subject has any disease or condition that interferes with safe completion of the study including:
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 |
|---|---|---|
| The truFreeze Spray CryotherapyA novel FDA cleared technique that allows for liquid nitrogen (LN2) to be delivered in a metered fashion via a catheter through a flexible bronchoscope. | Device | Intervention |
| Ballon dilationAn endoscopic balloon that is inflated with water to pressures between 45 and 131 psi (3-9 atm) using a syringe and pressure manometer. | Device | Intervention, Standard of care |
| Radial IncisionCarbon dioxide (CO2) laser or Monopolar electrocautery knife | Device | Intervention, Standard of care |
Primary outcome
Degree of re-stenosis
Time frame: 6 months
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.
3 secondary outcomes
Change in Peak Expiratory Flow (PEF)
Time frame: Continous for 6 months
Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ)
Time frame: 2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,
Incidence of complications between groups
Time frame: Continous for 6 months
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 10 Dec 2025.
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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.
Ray Shepherd principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing The truFreeze Spray Cryotherapy, Ballon dilation and Radial Incision in people with Stenosis Trachea, run by Virginia Commonwealth University 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 4 inclusion and 17 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 10 Dec 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 Ramsha Hamid ((804) 628-2176, ramsha.hamid@vcuhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Degree of re-stenosis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Dec 2025.