Single Use Bronchoscopes for Interventional Pulmonology

Not Applicable

Not yet recruiting

• Conditions: Bronchoscopic Interventions
• Interventions: Device: Single use bronchoscope

• Registration Number: NCT06596655
• Lead Sponsor: Beth Israel Deaconess Medical Center

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-05
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-14
• Last Update Posted: 2025-03-17
• Study Start: 2025-04-01
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Use of single use bronchoscope	Single use bronchoscope	-

Primary Outcome Measures

Name	Time	Method
Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist)	During the procedure