Recruiting

Surveillance vs. Bronchoscopy

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06935695

Conditions

Bronchial Stents

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bronchoscopy

Study Details

Brief summary:

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

Conditions

Bronchial Stents

Study ID

NCT06935695

Start date

Jan 1, 2025

Status verified date

Apr, 2025

Completion date

Mar 31, 2026

Anticipated

Primary completion date

Mar 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

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.

Interventions

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 measure

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

Central Contacts and Locations

Central contacts

Axel Duval, MD

‭(212) 824-8546‬axel.duval@mountsinai.org

Locations

The Mount Sinai Health System

Recruiting

New York, New York, United States, 10029

Contacts

Axel Duval, MD

axel.duval@mountsinai.org

Principal Investigator:

Udit Chaddha, MBBS

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Apr 20, 2025

Last verified

Apr, 2025

Keywords

  • Airway
  • Stent
  • Bronchoscopy
  • Surveillance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2025-04-20.