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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-02

Study Completion Date

2027-01-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cryospray Therapy Versus Standard of Care for Benign Airway Stenosis (CryoStasis)

NCT04996173

Pulmonary Disease

RECRUITING NA

Non-Invasive Neurostimulation of the Vagus Nerve With the AlphaCore Device for the Relief of EIB

NCT01923272

Asthma

WITHDRAWN NA

Tracheobronchomalacia: Treatment Outcomes

NCT00550602

Tracheomalacia Tracheobronchomalacia

COMPLETED

Evaluation of the Safety and Tolerability of Nitric Oxide (NO) Via Inhalation to Subjects With Bronchiolitis

NCT01768884

Bronchiolitis

COMPLETED PHASE1/PHASE2

Mucociliary Clearance Techniques in Moderate Bronchiolitis

NCT04553822

Bronchiolitis

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stenosis of Trachea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Interventional

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)

Group Type EXPERIMENTAL

Spray cryo therapy

Intervention Type PROCEDURE

normal flow, 5 seconds repeated for 3-5 cycles

Control

1. Steroid injection
2. Radial mucosal incision
3. Balloon dilation (to normal airway diameter)

Group Type ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type PROCEDURE

1. Steroid injection
2. Radial mucosal incision
3. Balloon dilation (to normal airway diameter)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Spray cryo therapy

normal flow, 5 seconds repeated for 3-5 cycles

Intervention Type PROCEDURE

Standard of Care (SOC)

1. Steroid injection
2. Radial mucosal incision
3. Balloon dilation (to normal airway diameter)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Adnan Majid, MD

Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology, Beth Israel Deaconess Medical Center, Professor of Medicine, Harvard Medical School,

Responsibility Role PRINCIPAL_INVESTIGATOR