To hear about similar clinical trials, please enter your email below
Trial Title:
Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs
NCT ID:
NCT05512533
Condition:
Peripheral Pulmonary Nodules
Conditions: Official terms:
Multiple Pulmonary Nodules
Conditions: Keywords:
EBUS-TBNA
peripheral pulmonary nodules (PPLs)
diagnostic yield
Study type:
Interventional
Study phase:
N/A
Overall status:
Unknown status
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Linear Ultrasound Bronchoscope BF-UC290F (Olympus)
Description:
A thin Olympus EBUS bronchoscope BF-UC290F will be used for all endobronchial ultrasound
examinations, and biopsies will be conducted with EBUS needles - the ViziShot 2 22G
(Olympus).
Arm group label:
BF-UC290F for diagnosing PPLs
Summary:
The purpose of the study is to evaluate the diagnostic value and safety of Thin Convex
Probe Endobronchial Ultrasound (TCP-EBUS) Scope for peripheral pulmonary lesions (PPLs)
Detailed description:
This study will determine the feasibility of the novel thin convex probe endobronchial
ultrasound (TCP-EBUS) Scope for the diagnosis of peripheral pulmonary lesions. The
primary end point is to clarify the feasibility of using the thin convex probe EBUS scope
to biopsy peripheral pulmonary lesions. The secondary objective is to evaluate operation
time, sample adequacy and quality, factors affecting the diagnosis rate, etc. The safety,
insertion ability, and operability of the thin convex probe EBUS would also be evaluated.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients older than 18 years old.
- Chest imaging shows the presence of peripheral pulmonary lesions (surrounded by
pulmonary parenchyma and located below the segmental bronchus/located at least 2
airway generations from the main carina as seen radiographically.) suspicious of
malignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for
clinical purposes, and the investigators consider it possible to be biopsied with
BF-UC290F (the bronchus adjacent or leading to the PPLs are ≥5mm in diameter, thus
BF-UC290F is able to arrival/access).
- Patients without contraindications of bronchoscopy.
- Patients have good medical adherence and signed informed consent.
Exclusion Criteria:
- Peripheral pulmonary lesion is pure ground-glass opacity.
- Visible lumen lesions during bronchoscopy
- The lesions were adjacent to the central airway (trachea, left and right main
bronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUS
Scope BF-UC290F were conducted without leaf bronchus entry
- The investigators believe that patient has other conditions that are not suitable
for the study.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Shanghai Chest Hospital
Address:
City:
Shanghai
Zip:
200030
Country:
China
Status:
Recruiting
Contact:
Last name:
Jiayuan Sun, MD
Email:
jysun1976@163.com
Investigator:
Last name:
Jiayuan Sun, MD
Email:
Principal Investigator
Start date:
August 22, 2022
Completion date:
October 31, 2023
Lead sponsor:
Agency:
Shanghai Chest Hospital
Agency class:
Other
Source:
Shanghai Chest Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05512533
