Surveillance Versus Bronchoscopy After Airway Stenting

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06935695
Status
Recruiting
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Conditions

  • Bronchial Stents

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting

Key Dates

Start date
Jan 1, 2025
Status verified
Apr 2025
Primary completion
Mar 31, 2026
Completion
Mar 31, 2026

Study Design

Enrollment
50 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Surveillance Group
    Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion.
  • Active Comparator: No Surveillance
    Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications.

Primary Outcome Measure

Number of stent-related complications warranting an intervention [ Time Frame: 3 months after enrollment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Mount Sinai Health SystemNew YorkNew York10029
Axel Duval, MD
[email protected]
Udit Chaddha, MBBS (PRINCIPAL_INVESTIGATOR)

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The Mount Sinai Health System· New York, NY