NCT06596655

Single Use Bronchoscopes for Interventional Pulmonology

Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures: A Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this pilot single-arm crossover trial is to investigate the feasibility and safety of using single-use flexible bronchoscopes (SUFB) for routine diagnostic and therapeutic interventional pulmonary procedures instead of reusable flexible bronchoscopes (RFB). The main questions it aims to answer are: Was a decision to crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) made ? Bronchoscopist's assessment of the SUFB for each procedure (using a Likert scale 0-10) including: 1. Overall assessment 2. Scope quality 3. Scope handling 4. Scope maneuverability 5. Tool compatibility 6. Suction 7. Lavage 8. Safety 9. Image quality Participants will undergo bronchoscopy with single use bronchoscopes.

Conditions

• Bronchoscopic Interventions

Interventions

Type	Name	Description
DEVICE	Single use bronchoscope	Use of single use bronchoscopes for interventional pulmonology procedures instead of reusable bronchoscopes.

Timeline

• Start date: 2025-05-23
• Primary completion: 2026-05-01
• Completion: 2027-10-01
• First posted: 2024-09-19
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study