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Clinical study on the application of lung puncture surgery navigation and positioning system in percutaneous lung puncture interventional surgery

Clinical trial on the safety and effectiveness of the lung puncture surgery navigation and positioning system in percutaneous lung puncture interventional surgery

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095919
Enrollment
Unknown
Registered
2025-01-15
Start date
2024-04-29
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

None

Interventions

Lung puncture group:Navigation and positioning system for lung puncture surgery for CT guided percutaneous localization of pulmonary nodules

Sponsors

Liaoning Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Age>= 18 years old and < 80 years old, gender not limited; (2)Patients who require preoperative localization of pulmonary nodules and meet any of the following criteria can be included in the study: a)Solitary peripheral nodules in the lungs with a diameter of less than 1cm and a tumor distance of more than 1.5cm from the lung edge; b)Imaging manifestations include pure ground glass nodules or sub solid nodules; c)Surgical personnel who have difficulty locating intraoperative nodules before surgery; (3)The patient fully understands the benefits and risks of this trial, is willing to participate in this trial, and signs an informed consent form.

Exclusion criteria

Exclusion criteria: (1)Patients with skin redness, swelling, damage, symptoms of skin diseases, inability to stick markers for skin diseases, or acute suppurative infections in the pleural cavity at the puncture site; (2)Irreversible coagulation dysfunction or significant abnormalities in coagulation function; (3)Pulmonary nodules are located in the scapular region that obstructs percutaneous localization; (4)Pulmonary nodules located near important organs such as mediastinum or large blood vessels in the heart; (5)After the first CT scan for localization, new changes were found in the patient's target lung nodules, such as decreased or disappeared lung nodule density, or the appearance of new lesions in the lungs, such as hospital acquired pneumonia (HAP), pneumothorax, etc., which may affect subsequent localization operations; (6)Patients with pneumothorax caused by other diseases such as pulmonary bullae or pulmonary cysts in the proposed puncture path; (7)There are obvious infectious lesions on the puncture path; (8)Anatomical or functional isolated lung; (9)Critical patients with severe heart, liver, lung, and kidney dysfunction: (10)Unable to cooperate, unable to control coughing, unable to tolerate puncture; (11)Pregnant or lactating women, as well as others who cannot receive intraoperative radiation; (12)The patient's scheduled surgery has been temporarily cancelled; (13)Individuals who have participated or are currently participating in other clinical trials within the 28 days prior to screening; (14)Researchers evaluate subjects with poor compliance or other reasons who are not suitable to participate in this trial.

Design outcomes

Primary

MeasureTime frame
Needle puncture accuracy rate;

Secondary

MeasureTime frame
Puncture accuracy;Positioning accuracy;Success rate of one needle positioning;radiation dosage;Operation time;Puncture frequency;Adverse event incidence rate;Equipment defect incidence rate;

Countries

China

Contacts

Public ContactLiu Hongxu

Liaoning Cancer Hospital

hongxuliu@qq.com+86 138 4000 4476

Outcome results

None listed

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