Single Use Bronchoscopes for Interventional Pulmonology
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Single use bronchoscope.
- Who it may be relevant to
- Registry conditions: Bronchoscopic Interventions. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures: A Feasibility Study
Overview
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.
Interventions
- Device Single use bronchoscope
Use of single use bronchoscopes for interventional pulmonology procedures instead of reusable bronchoscopes.
Primary outcome measures
- Incidence of crossover from SUFB to RFB (at the discretion of the clinical bronchoscopist) [Time frame: During the procedure]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 1 center
- Beth Israel Deaconess Medical Center — Boston
Identifiers
NCT: NCT06596655 · 2024P000471