Single Use Bronchoscopes for Interventional Pulmonology

ConditionBronchoscopic Interventions

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorBeth Israel Deaconess Medical Center

About 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 does not accept healthy volunteers

Qualifiers

Age 18 or older

Able to provide informed consent.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Use of single use bronchoscopeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist)

Time frame

During the procedure

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

Olympus

Collaborator

Source ClinicalTrials.gov

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