Single Use Bronchoscopes for Interventional Pulmonology

Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures: A Feasibility Study

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchoscopic Interventions
• Intervention / Treatment: Device: Single use bronchoscope

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine Conley; Phone Number: 617-632-8386; Email: Cconley@bidmc.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Beth Israel Deaconess Medical Center
      • Principal Investigator: Adnan Majid, MD
      • Contact: Christine Conley; Phone Number: 6176328386; Email: cconley@bidmc.harvard.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Use of single use bronchoscope	Device: Single use bronchoscope; Use of single use bronchoscopes for interventional pulmonology procedures instead of reusable bronchoscopes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist)	During the procedure

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Olympus

Study record dates

Study Major Dates

• Study Start (Actual): May 23, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: September 5, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2024P000471

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No