Bronchial StentsSCOPE-ITNCT06935695
Surveillance Versus Bronchoscopy After Airway Stenting
A study testing Bronchoscopy in people with Bronchial Stents, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial summary
Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchial Stents
- What is being tested?
- Bronchoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2025to 31 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The Mount Sinai Health System
New York, New York, 10029
Axel Duval, MD, axel.duval@mountsinai.org
Udit Chaddha, MBBS
About this study
Official title: 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
- Conditions
- Bronchial Stents
- Being tested
- Bronchoscopy
- Keywords
- Airway, Stent, Bronchoscopy, Surveillance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BronchoscopyDevice
Also called PRN 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.
| Study group | Role | What they receive |
|---|---|---|
| Surveillance Group | Experimental | Patients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion. Receives: Device: Bronchoscopy |
| No Surveillance | Active comparator | Patients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications. Receives: Device: Bronchoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of stent-related complications warranting an intervention
Possible complications:
Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention
Measured: 3 months after enrollment
Secondary outcomes (5)
Number of unscheduled visits due to stent-related complications
Number of unscheduled visits due to stent-related complications
Measured: 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
Measured: 3 months after enrollment
Number of hospitalizations due to stent-related complications
Number of hospitalizations due to stent-related complications
Measured: 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
Measured: 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.
Measured: 3 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Jan 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial StentsStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Udit Chaddha, Icahn School of Medicine at Mount Sinai
- Investigators
- Udit Chaddha, MBBS, Principal investigator, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06935695
- Sponsor's protocol ID
- STUDY-24-01352
- Acronym
- SCOPE-IT
- Status last verified
- Apr 2025
- First submitted
- 4 Apr 2025
- Last updated
- 20 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance Versus Prn bronChOscoPy aftEr aIrway stenTing (SCOPE-IT)
- ClinicalTrials.gov ID
- NCT06935695
- Acronym / sponsor ID
- SCOPE-IT / STUDY-24-01352
- Conditions
- Bronchial Stents
- Keywords
- Airway, Stent, Bronchoscopy, Surveillance
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 20 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Randomized, pilot study that evaluates surveillance bronchoscopy versus no surveillance for patients that undergo tracheobronchial stenting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surveillance Group | Experimental | Device: BronchoscopyPatients will be scheduled to undergo a surveillance bronchoscopy 4-6 weeks after the stent insertion. |
| No Surveillance | Active comparator | Device: BronchoscopyPatients will only undergo bronchoscopies if warranted by clinical symptoms deemed to be secondary to stent-related complications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All adult patients that undergo central airway (trachea, main stem bronchi and bronchus intermedius) stenting.
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BronchoscopyAlso: PRN bronchoscopyBronchoscopy 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. | Device | No Surveillance, Surveillance Group |
Primary outcome
Number of stent-related complications warranting an intervention
Time frame: 3 months after enrollment
Possible complications: Stent migration, biofilm formation, obstructive mucus plugging, obstructive granulation requiring intervention
5 secondary outcomes
Number of unscheduled visits due to stent-related complications
Time frame: 3 months after enrollment
Number of urgent care or emergency room visits due to stent-related complications
Time frame: 3 months after enrollment
Number of hospitalizations due to stent-related complications
Time frame: 3 months after enrollment
Number of stent-related complications as detected during a bronchoscopy or on cross-sectional imaging
Time frame: 3 months after enrollment
Protocol Feasibility Composite Score
Time frame: 3 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Udit Chaddha, MBBS principal investigator
Icahn School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bronchoscopy in people with Bronchial Stents, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Axel Duval, MD ((212) 824-8546, axel.duval@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of stent-related complications warranting an intervention (time frame: 3 months after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2025.