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Clinical trials to verify the safety and efficacy of Puncture Navigation System in lung ablation

Clinical trials to verify the safety and efficacy of Puncture Navigation System in lung ablation

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078180
Enrollment
Unknown
Registered
2023-11-30
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

Lung mass lesion

Interventions

Experimental group:Percutaneous lung ablation using a navigation robotic system

Sponsors

Anhui Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-80 years (inclusive), regardless of gender; 2. With clinical and imaging diagnosis of a lung mass lesion and the need for a percutaneous lung ablation; 3. With good compliance and cooperation in completing CT-guided percutaneous lung ablation and other requirements of this study; 4. Are able to voluntarily participate in the clinical trial and sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients with uncorrectable coagulation disorders or on anticoagulation therapy, or the last dose of bevacizumab was no more than 1 month apart; 2. Patients with bleeding tendencies; 3. Patients with severe cardiopulmonary insufficiency (e.g., severe pulmonary hypertension) or abnormal electrocardiogram within 1 week prior to surgery, presence of atrial fibrillation, severe myocardial ischemia or arrhythmia; 4. Patients with severe hepatic or renal insufficiency (glutamic aminotransferase (ALT) or glutamic oxalacetic aminotransferase (AST) > 5 times the upper limit of normal, alkaline phosphatase (ALP) > 5 times the upper limit of normal, total bilirubin (TBil) > 3 times the upper limit of normal, serum creatinine (Scr) > 178µmol/L ), combined with other clinical manifestations, as determined by the investigator; 5. Patients with severe emphysema, pulmonary bulla, pulmonary fibrosis, or chronic obstructive pulmonary disease that lung puncture is contraindicated; 6. Patients with suspected intrapulmonary cystic lesions, such as pulmonary encapsulopathy; 7. Pregnant or lactating women; 8. Patients using devices that are subject to electromagnetic interference (e.g., pacemakers) or implants that cause electromagnetic interference; 9. Patients with a previous medical history of allergy to enhanced CT contrast agents; 10. Patients with other contraindications for CT-guided percutaneous lung ablation or who are otherwise deemed unsuitable for enrollment by their physicians

Design outcomes

Primary

MeasureTime frame
Average times of CT scans during puncture;

Secondary

MeasureTime frame
Success rate of positioning;Operation time of positioning;Aiming accuracy;Mean dose length product;Fuctional assessment;

Countries

China

Contacts

Public ContactXuhong Min

Anhui Chest Hospital

631001342@qq.com+86 138 5517 9548

Outcome results

None listed

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