Evaluate the Diagnostic Value of BTPNA for PPL: a Real-world Study

NCT04597346 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2023-02-23

No results posted yet for this study

Summary

The study is designed as a multicenter prospective trial of BTPNA for the diagnosis of peripheral pulmonary lesions in the real world. The purpose of the study is to evaluate the safety and effectiveness of BTPNA and to explore the factors of diagnosis rate.

Conditions

  • Peripheral Pulmonary Lesion

Interventions

DEVICE

Bronchoscopic Transparenchymal Nodule Access

Bronchoscopic Transparenchymal Nodule Access (BTPNA) is locating the lesion in the lung tissue guided by the bronchoscope navigation system (LungPro) in the natural lumen (bronchus), and automatically calculates the best point of entry (POE) and the best route to avoid blood vessels. An opening is made from the POE under the endoscope, and is extended with a balloon dilator. Combined with X-ray fluoroscopy, a sheath with a blunt-tip core is used in the lung parenchyma to reach the lesion site, and then biopsy diagnosis or treatment.

Sponsors & Collaborators

  • Henan Provincial People's Hospital

    collaborator OTHER
  • Beijing Chao Yang Hospital

    collaborator OTHER
  • Shandong Public Health Clinical Center

    collaborator OTHER_GOV
  • West China Hospital

    collaborator OTHER
  • Second Affiliated Hospital of Guangzhou Medical University

    collaborator OTHER
  • Xi 'an International Medical Center Hospital

    collaborator UNKNOWN
  • Emergency General Hospital

    collaborator OTHER
  • Shanghai Chest Hospital

    lead OTHER

Principal Investigators

  • Jiayuan Sun, MD, PhD · Shanghai Chest Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-23
Primary Completion
2023-12-30
Completion
2024-06-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04597346 on ClinicalTrials.gov