Bronchoscopic InterventionsNCT06596655
Single Use Bronchoscopes for Interventional Pulmonology
A study testing Single use bronchoscope in people with Bronchoscopic Interventions, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchoscopic Interventions
- What is being tested?
- Single use bronchoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Able to provide informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Christine Conley, 6176328386, cconley@bidmc.harvard.edu
Adnan Majid, MD
About this study
Official title: 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 ?
Read more
Bronchoscopist's assessment of the SUFB for each procedure (using a Likert scale 0-10) including:
- Overall assessment
- Scope quality
- Scope handling
- Scope maneuverability
- Tool compatibility
- Suction
- Lavage
- Safety
- Image quality
Participants will undergo bronchoscopy with single use bronchoscopes.
- Conditions
- Bronchoscopic Interventions
- Being tested
- Single use bronchoscope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single use bronchoscopeDevice
Use of single use bronchoscopes for interventional pulmonology procedures instead of reusable bronchoscopes.
| Study group | Role | What they receive |
|---|---|---|
| Use of single use bronchoscope | Experimental | Not described Receives: Device: Single use bronchoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist)
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start23 May 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchoscopic InterventionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Principal investigator, Adnan Majid, MD, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596655
- Sponsor's protocol ID
- 2024P000471
- Status last verified
- Aug 2026
- First submitted
- 5 Sep 2024
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures: A Feasibility Study
- ClinicalTrials.gov ID
- NCT06596655
- Acronym / sponsor ID
- 2024P000471
- Conditions
- Bronchoscopic Interventions
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- 23 May 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Overall assessment
- Scope quality
- Scope handling
- Scope maneuverability
- Tool compatibility
- Suction
- Lavage
- Safety
- Image quality
Participants will undergo bronchoscopy with single use bronchoscopes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of single use bronchoscope | Experimental | Device: Single use bronchoscope |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Able to provide informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Single use bronchoscopeUse of single use bronchoscopes for interventional pulmonology procedures instead of reusable bronchoscopes. | Device | Use of single use bronchoscope |
Primary outcome
Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist)
Time frame: During the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single use bronchoscope in people with Bronchoscopic Interventions, run by Beth Israel Deaconess Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christine Conley (617-632-8386, Cconley@bidmc.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.