Surveillance Versus Bronchoscopy After Airway Stenting (SCOPE-IT)

Surveillance Versus Prn bronChOscoPy aftEr aIrway stenTing (SCOPE-IT)

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

Study Overview

• Status: Recruiting
• Conditions: Bronchial Stents
• Intervention / Treatment: Device: Bronchoscopy

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Axel Duval, MD; Phone Number: ‭(212) 824-8546‬; Email: axel.duval@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • The Mount Sinai Health System
      • Contact: Axel Duval, MD; Email: axel.duval@mountsinai.org
      • Principal Investigator: Udit Chaddha, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Surveillance Group; Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion.	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.; Other Names: PRN bronchoscopy
Active Comparator: No Surveillance; Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications.	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.; Other Names: PRN bronchoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of unscheduled visits due to stent-related complications	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	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	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	Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging	3 months after enrollment
Protocol Feasibility Composite Score	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.	3 months after enrollment

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Udit Chaddha, MBBS, Icahn School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2025
• Primary Completion (Estimated): March 31, 2026
• Study Completion (Estimated): March 31, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 11, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): April 20, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Stent; Bronchoscopy; Surveillance; Airway
• Other Study ID Numbers: STUDY-24-01352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
• IPD Sharing Time Frame: Beginning 9 months and ending 36 months following article publication.

IPD Sharing 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).

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No