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Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surveillance Group | Experimental | Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion. |
|
| No Surveillance | Active Comparator | Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bronchoscopy | Device | Bronchoscopy is a procedure that uses a bronchoscope (a thin, tube-like instrument with a light and a lens for viewing) to examine the inside of the trachea, bronchi (air passages that lead to the lungs), and lungs. The bronchoscope is inserted through the nose or mouth. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of stent-related complications warranting an intervention | Possible complications: Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention | 3 months after enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of unscheduled visits due to stent-related complications | Number of unscheduled visits due to stent-related complications | 3 months after enrollment |
| Number of urgent care or emergency room visits due to stent-related complications |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Axel Duval, MD | Contact | â€(212) 824-8546‬ | axel.duval@mountsinai.org |
| Name | Affiliation | Role |
|---|---|---|
| Udit Chaddha, MBBS | Icahn School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mount Sinai Health System | Recruiting | New York | New York | 10029 | United States |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Beginning 9 months and ending 36 months following article publication.
Investigators whose proposed use of the data has been approved by an independent review committee ('learned intermediary') identified for this purpose.
For individual participant data meta-analysis. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in Mount Sinai's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (to be determined).
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| ID | Term |
|---|---|
| D001999 | Bronchoscopy |
| ID | Term |
|---|---|
| D003948 | Diagnostic Techniques, Respiratory System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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Number of urgent care or emergency room visits due to stent-related complications
| 3 months after enrollment |
| Number of hospitalizations due to stent-related complications | Number of hospitalizations due to stent-related complications | 3 months after enrollment |
| Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging | Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging | 3 months after enrollment |
| Protocol Feasibility Composite Score | A composite score comprised from recruitment success (enrollment of target participant numbers), protocol adherence, data completeness, intervention safety, and resource availability to measure protocol feasibility. The total scale for the composite score is 1 to 5, with higher score indicating more feasibility. | 3 months after enrollment |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |