Single Use Bronchoscopes for Bronchoscopic Interventions

Overseen By Christine Conley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Beth Israel Deaconess Medical Center

Must not be taking: Anticoagulants, Antiplatelets

Disqualifiers: Pregnancy, Cardiopulmonary instability, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for adults aged 18 or older who can give informed consent and require bronchoscopic interventions. The study excludes individuals who do not meet these criteria.

Inclusion Criteria

I can understand and agree to the study's procedures and risks.

I am 18 years old or older.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo bronchoscopy with single-use bronchoscopes for routine diagnostic and therapeutic interventional pulmonary procedures

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the bronchoscopy procedure

4 weeks

Treatment Details

Interventions

• Single Use Bronchoscopes

Trial Overview The study tests the use of single-use flexible bronchoscopes (SUFB) for pulmonary procedures, assessing their feasibility and safety compared to reusable ones. Participants will undergo routine diagnostic and therapeutic procedures with SUFBs.

Participant Groups

Group I: Use of single use bronchoscope Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Beth Israel Deaconess Medical Center

Lead Sponsor

Trials

872

Recruited

12,930,000+

Olympus

Industry Sponsor

Trials

22

Recruited

3,600+