Recruiting

Single-Use Bronchoscopes

Sponsor:

Beth Israel Deaconess Medical Center

Code:

NCT06596655

Conditions

Bronchoscopic Interventions

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Single use bronchoscope

Study Details

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.

Conditions

Bronchoscopic Interventions

Study ID

NCT06596655

Start date

May 23, 2025

Status verified date

Aug, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Use of single use bronchoscope

Interventions

Single use bronchoscope

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

Primary outcome measure

  • Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) [ Time Frame: During the procedure ]

Central Contacts and Locations

Central contacts

Christine Conley

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

Locations

Beth Israel Deaconess Medical Center

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Christine Conley

6176328386cconley@bidmc.harvard.edu

Principal Investigator:

Adnan Majid, MD

More Information

Sponsor

Beth Israel Deaconess Medical Center

Last update posted

Aug 27, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Beth Israel Deaconess Medical Center on 2026-08-27.