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Recruiting
NCT06596655
Single Use Bronchoscopes for Interventional Pulmonology
Conditions: Bronchoscopic Interventions
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 20
Sponsor: Beth Israel Deaconess Medical Center
Location: Beth Israel Deaconess Medical Center Boston Massachusetts
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06596655). StuddyBuddy aggregates publicly available trial information.