The Mount Sinai Health System
New York, 10029, United States
Location status: Recruiting
Recruiting
NCT Number: NCT06935695
Surveillance Versus Bronchoscopy After Airway Stenting
Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting
Recruiting
Interested in participating?
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.
Exclusion criteria
- Inability to obtain informed consent due to cognitive, neurologic or psychiatric impairment.
- Lobar or segmental stents alone
- Terminally ill patients considered too sick to undergo a follow-up surveillance bronchoscopy
- Stent insertion as a trial for excessive central airway collapse (as the duration of these stents is only 1-2 weeks)
- Patients with a tracheostomy (as these patients can undergo frequent in-line suctioning that can affect the outcomes being assessed)
Treatment and study plan
Bronchoscopy
DeviceBronchoscopy 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.
Other names: PRN bronchoscopy
Primary outcomes
-
Number of stent-related complications warranting an intervention
Time frame: 3 months after enrollment
Possible complications:
Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention
Secondary outcomes
-
Number of unscheduled visits due to stent-related complications
Time frame: 3 months after enrollment
Number of unscheduled visits due to stent-related complications
-
Number of urgent care or emergency room visits due to stent-related complications
Time frame: 3 months after enrollment
Number of urgent care or emergency room visits due to stent-related complications
-
Number of hospitalizations due to stent-related complications
Time frame: 3 months after enrollment
Number of hospitalizations due to stent-related complications
-
Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging
Time frame: 3 months after enrollment
Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging
-
Protocol Feasibility Composite Score
Time frame: 3 months after enrollment
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.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Icahn School of Medicine at Mount Sinai
Other
Registry information
Official study title
Surveillance Versus Prn bronChOscoPy aftEr aIrway stenTing (SCOPE-IT)
Acronym: SCOPE-IT
Important dates
- Study start
- 2025
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Apr 20, 2025
- Registry last updated
- Apr 20, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.