Feasibility of Thin Cp-EBUS Scope BF-UC290F for the Diagnosis of PPLs

Last updated: August 24, 2022
Sponsor: Shanghai Chest Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Nodules

Treatment

N/A

Clinical Study ID

NCT05512533
SHCHE202208
  • Ages > 18
  • All Genders

Study 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)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients older than 18 years old.
  • Chest imaging shows the presence of peripheral pulmonary lesions (surrounded bypulmonary parenchyma and located below the segmental bronchus/located at least 2airway generations from the main carina as seen radiographically.) suspicious ofmalignancy, 0.8-5cm in greatest diameter in need of bronchoscopic biopsy for clinicalpurposes, 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 isable to arrival/access).
  • Patients without contraindications of bronchoscopy.
  • Patients have good medical adherence and signed informed consent.

Exclusion

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 mainbronchus, and right middle bronchus), and the biopsies by the Thin Convex Probe EBUSScope BF-UC290F were conducted without leaf bronchus entry
  • The investigators believe that patient has other conditions that are not suitable forthe study.

Study Design

Total Participants: 30
Study Start date:
August 22, 2022
Estimated Completion Date:
October 31, 2023

Study 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.

Connect with a study center

  • Shanghai Chest Hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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