Recruiting NCT06935695
Surveillance Versus Bronchoscopy After Airway Stenting
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bronchoscopy.
- Who it may be relevant to
- Registry conditions: Bronchial Stents. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Surveillance Versus Prn bronChOscoPy aftEr aIrway stenTing (SCOPE-IT)
Overview
Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting
Interventions
- Device Bronchoscopy
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.
Primary outcome measures
- Number of stent-related complications warranting an intervention [Time frame: 3 months after enrollment]
Secondary outcome measures (5)
- Number of unscheduled 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 [Time frame: 3 months after enrollment]
- Number of hospitalizations due to stent-related complications [Time frame: 3 months after enrollment]
- Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging [Time frame: 3 months after enrollment]
- Protocol Feasibility Composite Score [Time frame: 3 months after enrollment]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
United States · 1 center
- The Mount Sinai Health System — New York
Identifiers
NCT: NCT06935695 · STUDY-24-01352