Surveillance Versus Bronchoscopy After Airway Stenting

NCT ID: NCT06935695

Last Updated: 2025-04-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchial Stents

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Surveillance Group

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

Group Type EXPERIMENTAL

Bronchoscopy

Intervention Type 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.

No Surveillance

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

Group Type ACTIVE_COMPARATOR

Bronchoscopy

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PRN bronchoscopy

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Udit Chaddha

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Udit Chaddha, MBBS

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Mount Sinai Health System

New York, New York, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Axel Duval, MD

Role: CONTACT

‭(212) 824-8546‬

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Axel Duval, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY-24-01352

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Assisted Intubation
NCT01312155 COMPLETED