Comparing surveillance bronchoscopy to no surveillance after airway stenting
Surveillance Versus Prn bronChOscoPy aftEr aIrway stenTing (SCOPE-IT)
This study is testing whether regular check-ups with a bronchoscopy after getting airway stents can help patients manage their condition better than not having these check-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06935695 on ClinicalTrials.gov |
What this trial studies
This pilot study randomly assigns adult patients who have undergone central airway stenting to either receive surveillance bronchoscopy or not. The aim is to evaluate the effectiveness of surveillance bronchoscopy in monitoring patients post-stenting. The study focuses on patients with tracheobronchial stents and assesses the outcomes related to airway management. By comparing these two approaches, the study seeks to determine the best follow-up care for patients with airway stents.
Who should consider this trial
Good fit: Ideal candidates are adult patients who have undergone central airway stenting.
Not a fit: Patients who are terminally ill or have cognitive impairments may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve post-stenting care and outcomes for patients with airway obstructions.
How similar studies have performed: Similar studies have explored bronchoscopy techniques, but this specific comparison of surveillance versus no surveillance is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
New York, New York
- The Mount Sinai Health System — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Udit Chaddha, MBBS — Icahn School of Medicine
- Study coordinator: Axel Duval, MD
- Email: axel.duval@mountsinai.org
- Phone: (212) 824-8546
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.