Single Use Bronchoscopes for Interventional Pulmonology

NCT ID: NCT06596655

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-23

Study Completion Date

2026-10-01

Brief Summary

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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

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Conditions

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Bronchoscopic Interventions

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Use of single use bronchoscope

Group Type EXPERIMENTAL

Single use bronchoscope

Intervention Type DEVICE

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

Interventions

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Single use bronchoscope

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Olympus

INDUSTRY

Sponsor Role collaborator

Beth Israel Deaconess Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Adnan Majid, MD

Chief, Section of Interventional Pulmonology, Division of Thoracic Surgery and Interventional Pulmonology,

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Christine Conley

Role: CONTACT

617-632-8386

Facility Contacts

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Christine Conley

Role: primary

6176328386

Other Identifiers

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2024P000471

Identifier Type: -

Identifier Source: org_study_id

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