Single-use flexible bronchoscopes for interventional pulmonology procedures
Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures: A Feasibility Study
NA · Beth Israel Deaconess Medical Center · NCT06596655
This tests whether single-use flexible bronchoscopes are safe and work well for adults undergoing routine diagnostic or therapeutic bronchoscopic procedures.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06596655 on ClinicalTrials.gov |
What this trial studies
This is a pilot single-arm crossover study at a single academic center using single-use flexible bronchoscopes (SUFB) for routine diagnostic and therapeutic bronchoscopic procedures. Bronchoscopists perform procedures with SUFB and may switch to a reusable flexible bronchoscope (RFB) at their discretion if needed. After each procedure clinicians rate the SUFB on a 0–10 Likert scale across domains such as image quality, handling, maneuverability, suction, lavage, tool compatibility, and safety. The trial primarily focuses on feasibility and procedural safety signals rather than clinical outcomes.
Who should consider this trial
Good fit: Adults aged 18 or older who can give informed consent and are scheduled for non-emergent diagnostic or therapeutic bronchoscopy are ideal candidates.
Not a fit: Patients undergoing emergent procedures, who are pregnant, or who have unstable cardiopulmonary status or uncorrected anticoagulation are unlikely to be eligible or benefit from participation.
Why it matters
Potential benefit: If successful, single-use bronchoscopes could lower cross-infection risk and simplify workflow by removing the need for reprocessing and immediate device availability concerns.
How similar studies have performed: Single-use bronchoscopes have shown promising feasibility and infection-control advantages in other settings, but comparative data for complex interventional procedures remain limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 or older * Able to provide informed consent. Exclusion Criteria: 1. Emergent procedure 2. Pregnancy 3. Study subjects have any diseases or conditions that interferes with safe completion of the biopsy including: cardiopulmonary instability; sensitivity to drugs that could be administered during bronchoscopy; active anticoagulation or antiplatelet therapy (warfarin, direct Xa inhibitors, thrombin inhibitors, low molecular weight heparin, unfractioned heparin, clopidogrel) not held adequately prior to the procedure; uncontrolled blood dyscrasias; concurrent pneumothorax or bullae.
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Study coordinator: Christine Conley
- Email: Cconley@bidmc.harvard.edu
- Phone: 617-632-8386
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.
Conditions: Bronchoscopic Interventions