RECRUITING

Cryospray Therapy for Benign Airway Stenosis

Conditions

Stenosis Trachea cryospray therapy benign airway stenosis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Cryospray Therapy for Benign Airway Stenosis: a Pilot Study (Pilot-CRYOSTASIS)

Quick Facts

Study Start:2023-10-12

Study Completion:2025-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06085209

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* 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	* 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: 1. Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula 2. Pneumothorax in the previous 12 months 3. Severe COPD (defined as a FEV1/FVC \< 70% and FEV1 \<30% predicted) and/or severe persistent asthma. 4. 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. 5. Compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs. 6. Significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. PEG tube) 7. 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.

Inclusion Criteria

Exclusion Criteria

* 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

* 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:
1. Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula
2. Pneumothorax in the previous 12 months
3. Severe COPD (defined as a FEV1/FVC \< 70% and FEV1 \<30% predicted) and/or severe persistent asthma.
4. 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.
5. Compromised tissue where significant ulceration or mucosal break is evident in the ablation area or adjacent organs.
6. Significantly reduced tissue strength caused by prior procedure or pre-existing condition (e.g. PEG tube)
7. 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.

Contacts and Locations

Study Contact

Ramsha Hamid

CONTACT

(804) 628-2176

ramsha.hamid@vcuhealth.org

Principal Investigator

Ray Shepherd

PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Study Locations (Sites)

Virgnia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

Ray Shepherd, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-12

Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-10-12

Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

cryospray therapy
benign airway stenosis

Additional Relevant MeSH Terms

Stenosis Trachea