Single Use Bronchoscopes for Interventional Pulmonology

Conditions

• Bronchoscopic Interventions

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Single use bronchoscope — DEVICE
  Use of single use bronchoscopes for interventional pulmonology procedures instead of reusable bronchoscopes.

Study Details

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.

Key Dates

Start date

May 23, 2025

Status verified

May 2025

Primary completion

May 1, 2026

Completion

Oct 1, 2027

Study Design

Enrollment

20 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Arms

• Experimental: Use of single use bronchoscope

Primary Outcome Measure

Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) [ Time Frame: During the procedure ]

Central Contacts

• Christine Conley
  617-632-8386
  [email protected]

Locations (1)

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