Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06596655
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
Single Use Bronchoscopes for Interventional Pulmonology
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Implementation of Low-Cost Single-Use Flexible Bronchoscopes for Routine Interventional Pulmonary Procedures a Feasibility Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Bronchoscopists 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
Was a decision to crossover from SUFB to RFB at the discretion of the clinical bronchoscopist made
Bronchoscopists 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None