Single Use Bronchoscopes for Interventional Pulmonology

NCT06596655 | Recruiting FDA Device

• 1 other identifier: 2024P000471
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 1.Overall assessment
2. 2.Scope quality
3. 3.Scope handling
4. 4.Scope maneuverability
5. 5.Tool compatibility
6. 6.Suction
7. 7.Lavage
8. 8.Safety
9. 9.Image quality

Conditions

Bronchoscopic Interventions

Outcome Measures

Primary Outcomes (1)

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

  During the procedure

Study Arms (1)

Use of single use bronchoscope

EXPERIMENTAL

Device: Single use bronchoscope

Interventions

Single use bronchoscope DEVICE

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

Use of single use bronchoscope

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Olympus: collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

RECRUITING

Central Study Contacts

Christine Conley

CONTACT

617-632-8386; Cconley@bidmc.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology,

Study Record Dates

• First Submitted: September 5, 2024
• First Posted: September 19, 2024
• Study Start: May 23, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)