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| Name | Class |
|---|---|
| American Association of Broncology and Interventional Pulmonology | UNKNOWN |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interventional | Experimental |
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| Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spray cryo therapy | Procedure | normal flow, 5 seconds repeated for 3-5 cycles |
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| Measure | Description | Time Frame |
|---|---|---|
| Need of re intervention | Number of patients that require new intervention for the benign airway stenosis. | Need of re intervention in two years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to re intervention | Time it takes in days for a patient to need a re intervention for the benign airway stenosis after treatment. | Two years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christine Conley | Contact | 617-632-8386 | Cconley@bidmc.harvard.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Recruiting | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23953005 | Background | Leong P, Bardin PG, Lau KK. What's in a name? Expiratory tracheal narrowing in adults explained. Clin Radiol. 2013 Dec;68(12):1268-75. doi: 10.1016/j.crad.2013.06.017. Epub 2013 Aug 13. |
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| ID | Term |
|---|---|
| D014135 | Tracheal Stenosis |
| ID | Term |
|---|---|
| D014133 | Tracheal Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of Care (SOC) |
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