RecruitingNot ApplicableNCT06596655

Single Use Bronchoscopes for Interventional Pulmonology

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


Sponsor

Beth Israel Deaconess Medical Center

Enrollment

20 participants

Start Date

May 23, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • Age 18 or older
  • Able to provide informed consent.

Exclusion Criteria3

  • Emergent procedure
  • Pregnancy
  • 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.

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Interventions

DEVICESingle use bronchoscope

Use of single use bronchoscopes for interventional pulmonology procedures instead of reusable bronchoscopes.


Locations(1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

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NCT06596655