RECRUITING

Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS)

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

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.

Official Title

Spray Cryotherapy for the Management of Benign Central Airway Stenosis (Cryo-BAS): A Randomized Controlled Trial

Quick Facts

Study Start:2025-06-02
Study Completion:2027-01-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06761170

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:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1. Patients with symptomatic, benign, simple stenosis of the trachea and/or subglottic space.
  2. * 2. Stenotic airway of diameter \< 1cm.
  1. 1. Complex stenosis, cartilage involvement (malacia or fracture).
  2. 2. Patients with giant bullae (\> a third of hemithorax) or bullae \>3cm.
  3. 3. Concurrent tracheoesophageal fistula, active tracheal malignancy.
  4. 4. Presence of concomitant upper airway obstruction.
  5. 5. Pregnancy

Contacts and Locations

Study Contact

Christine Conley
CONTACT
617-632-8386
Cconley@bidmc.harvard.edu

Study Locations (Sites)

Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States

Collaborators and Investigators

Sponsor: Beth Israel Deaconess Medical Center

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 Date2025-06-02
Study Completion Date2027-01-15

Study Record Updates

Study Start Date2025-06-02
Study Completion Date2027-01-15

Terms related to this study

Keywords Provided by Researchers

  • Stenosis of trachea
  • benign
  • spray cryotherapy

Additional Relevant MeSH Terms

  • Stenosis of Trachea