Cryospray Therapy for Benign Airway Stenosis

NCT ID: NCT06085209

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-12
• Study Completion Date: 2026-12-30

Brief 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. 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.

Conditions

Stenosis Trachea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intervention

Bronchoscopic balloon dilation with radial cuts \& truFreeze spray cryotherapy

Group Type: EXPERIMENTAL

The truFreeze Spray Cryotherapy

Intervention Type: DEVICE

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 dilation

Intervention Type: DEVICE

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 Incision

Intervention Type: DEVICE

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Standard of care

Bronchoscopic balloon dilation with radial cuts

Group Type: ACTIVE_COMPARATOR

Ballon dilation

Intervention Type: DEVICE

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 Incision

Intervention Type: DEVICE

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Interventions

The truFreeze Spray Cryotherapy

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.

Intervention Type: DEVICE

Ballon dilation

An endoscopic balloon that is inflated with water to pressures between 45 and 131 psi (3-9 atm) using a syringe and pressure manometer.

Intervention Type: DEVICE

Radial Incision

Carbon dioxide (CO2) laser or Monopolar electrocautery knife

Intervention Type: DEVICE

Eligibility Criteria

Inclusion 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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

US Endoscopy Group Inc.

INDUSTRY

Sponsor Role: collaborator

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ray Shepherd

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virgnia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ramsha Hamid

Role: CONTACT

ramsha.hamid@vcuhealth.org

(804) 628-2176

Facility Contacts

Ray Shepherd

Role: primary

ray.shepherd@vcuhealth.org

804-828-9071

Ramsha Hamid

Role: backup

ramsha.hamid@vcuhealth.org

(804) 628-2176

Other Identifiers

HM20027230

Identifier Type: -

Identifier Source: org_study_id