Surveillance Versus Bronchoscopy After Airway Stenting

NCT06935695 | Recruiting DMC FDA Device

• 1 other identifier: STUDY-24-01352
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Bronchial Stents

Keywords

Airway; Stent; Bronchoscopy; Surveillance

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

  3 months after enrollment

• 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

  3 months after enrollment

• Protocol Feasibility Composite Score

  3 months after enrollment

Study Arms (2)

Surveillance Group

EXPERIMENTAL

Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion.

Device: Bronchoscopy

No Surveillance

ACTIVE COMPARATOR

Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications.

Device: Bronchoscopy

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.

Also known as: PRN bronchoscopy

No Surveillance; Surveillance Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

The Mount Sinai Health System

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Interventions

Bronchoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Respiratory System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Pulmonary Surgical Procedures; Thoracic Surgical Procedures

Study Officials

• Udit Chaddha, MBBS

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Axel Duval, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 20, 2025
• Study Start: January 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: April 20, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: 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).

Locations

US (1)