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A Prospective, Multicenter, Single Group Target Value Method Was Used to Evaluate the Safety and Effectiveness of Puncture Navigation Positioning Software and Pulmonary Surgery Marking System(JediVision-Lungbrella)for Preoperative Localization of Small Pulmonary Nodules

A Prospective, Multicenter, Single Group Target Value Method Was Used to Evaluate the Safety and Effectiveness of Puncture Navigation Positioning Software and Pulmonary Surgery Marking System(JediVision-Lungbrella)for Preoperative Localization of Small Pulmonary Nodules

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055612
Enrollment
Unknown
Registered
2022-01-14
Start date
2022-01-28
Completion date
Unknown
Last updated
2023-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localization of target lesions before lung surgery

Interventions

Treatment group:Localization of small pulmonary nodules by puncture navigation software and pulmonary surgery marker system(JediVision-Lungbrella)

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 80 years, gender is not limited; 2. Chest CT examination confirmed pulmonary nodules (diameter =< 2 cm) and thoracoscopic resection was planned; 3. The researchers judged that it was necessary to perform preoperative puncture location; 4. The patients who voluntarily participated and signed the informed consent can cooperate with the patients who completed the whole trial process. The subjects or their guardians can understand the purpose of the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with two or more pulmonary nodules in the segment of the target lesion; 2. Chest CT showed obvious enlarged hilar or mediastinal lymph nodes; 3. Patients who are not suitable for puncture location before operation, such as pleural effusion, severe lung tissue damage, chest adhesion, etc; 4. The subject had undergone chest surgery on the affected side; 5. Patients with important organ failure or other serious diseases; 6. Pregnant or lactating women; 7. At the same time, he participated in clinical trials of other drugs or medical devices; 8. Other conditions not suitable for inclusion were judged by the researchers.

Design outcomes

Primary

MeasureTime frame
Treatment success rate;Operation time;

Secondary

MeasureTime frame
Positioning accuracy;Positioning success rate;Puncture location time;Device performance evaluation;

Countries

China

Contacts

Public ContactLiu Lunxu

West China Hospital of Sichuan University

lunxu_liu@aliyun.com+86 18980601525

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026