search
Back to results

Cryospray Therapy for Benign Airway Stenosis (CRYOSTASIS)

Primary Purpose

Stenosis Trachea

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
The truFreeze Spray Cryotherapy
Ballon dilation
Radial Incision
Sponsored by
Virginia Commonwealth University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stenosis Trachea focused on measuring cryospray therapy, benign airway stenosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula 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.

Sites / Locations

  • Virgnia Commonwealth UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Standard of care

Arm Description

Bronchoscopic balloon dilation with radial cuts & truFreeze spray cryotherapy

Bronchoscopic balloon dilation with radial cuts

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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).
Incidence of complications between groups
Incidence of complications (hypoxemia, bleeding, pneumothorax rate, barotrauma).

Full Information

First Posted
September 28, 2023
Last Updated
October 19, 2023
Sponsor
Virginia Commonwealth University
Collaborators
US Endoscopy Group Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT06085209
Brief Title
Cryospray Therapy for Benign Airway Stenosis
Acronym
CRYOSTASIS
Official Title
Cryospray Therapy for Benign Airway Stenosis: a Pilot Study (Pilot-CRYOSTASIS)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 30, 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
Collaborators
US Endoscopy Group Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis Trachea
Keywords
cryospray therapy, benign airway stenosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
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
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Bronchoscopic balloon dilation with radial cuts & truFreeze spray cryotherapy
Arm Title
Standard of care
Arm Type
Active Comparator
Arm Description
Bronchoscopic balloon dilation with radial cuts
Intervention Type
Device
Intervention Name(s)
The truFreeze Spray Cryotherapy
Intervention Description
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
Intervention Name(s)
Ballon dilation
Intervention Description
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
Intervention Name(s)
Radial Incision
Intervention Description
Carbon dioxide (CO2) laser or Monopolar electrocautery knife
Primary Outcome Measure Information:
Title
Degree of re-stenosis
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in Peak Expiratory Flow (PEF)
Description
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.
Time Frame
Continous for 6 months
Title
Clinical Chronic Obstructive Pulmonary Disease Questionnaire (CCQ)
Description
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).
Time Frame
2 weeks before procedure, 2 weeks after the procedure, the 3 month study mark, the 6 months study mark,
Title
Incidence of complications between groups
Description
Incidence of complications (hypoxemia, bleeding, pneumothorax rate, barotrauma).
Time Frame
Continous for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: Hypoxemia with need for supplemental oxygen ≥ 2L/min by nasal canula 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ramsha Hamid
Phone
(804) 628-2176
Email
ramsha.hamid@vcuhealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ray Shepherd
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virgnia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray Shepherd
Phone
804-828-9071
Email
ray.shepherd@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
Ramsha Hamid
Phone
(804) 628-2176
Email
ramsha.hamid@vcuhealth.org

12. IPD Sharing Statement

Learn more about this trial

Cryospray Therapy for Benign Airway Stenosis

We'll reach out to this number within 24 hrs