NCT06596655NARecruiting

Single Use Bronchoscopes for Interventional Pulmonology

Beth Israel Deaconess Medical Center

Start Date

5/23/2025

Completion Date

10/1/2027

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DEVICE

Single use bronchoscope

Interested in This Trial?

Contact the trial locations directly using the information below to learn more about enrollment.

Expressing interest lets you review the study and consent before we connect you with the research site.

Conditions

Bronchoscopic Interventions

Locations

Beth Israel Deaconess Medical Center

Boston, Massachusetts 02215

United States