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NCT Number: NCT06596655

Single Use Bronchoscopes for Interventional Pulmonology

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.

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Key information

Conditions

Bronchoscopic Interventions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location status: Recruiting

Location contact

Adnan Majid, MD

PRINCIPAL_INVESTIGATOR

Christine Conley

CONTACT

[email protected]

6176328386

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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.

Treatment and study plan

Single use bronchoscope

Device

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

Primary outcomes

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

    Time frame: During the procedure

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Conley

CONTACT

[email protected]

617-632-8386

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • Olympus

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Sep 19, 2024
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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