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Clinical trial evaluating the safety and efficacy of the puncture surgery navigation and positioning system for the localization of lung and abdominal space-occupying lesions

Clinical trial evaluating the safety and efficacy of the puncture surgery navigation and positioning system for the localization of lung and abdominal space-occupying lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500113330
Enrollment
Unknown
Registered
2025-11-27
Start date
2025-12-15
Completion date
Unknown
Last updated
2025-12-01

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

Conditions

Diseases requiring lung and solid organ puncture or surgery

Interventions

Experimental group:Clinicians use the puncture surgery navigation positioning system to perform CT-guided percutaneous positioning surgeries for thoracic and abdominal mass lesions.
Control group:Clinicians use traditional coaxial guiding biopsy needles to perform CT-guided percutaneous puncture and localization surgeries for thoracic and abdominal mass lesions.

Sponsors

Shanghai Chest Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: The participants who can be included in this study must meet all of the following conditions: 1. Age ranging from 18 years to 80 years old, with no gender restrictions; 2. Diagnosed with a chest or abdominal space-occupying lesion by clinical and imaging methods, and the investigator determines that a puncture operation is necessary for the patient; 3. Lesions with a diameter ranging from 8mm to 50mm; 4. Voluntarily participating in the clinical trial and signing the informed consent form.

Exclusion criteria

Exclusion criteria: In any of the following circumstances, the subjects should not participate in the trial: 1. Patients with severe heart or lung dysfunction, as assessed by the researchers, are not suitable to participate in this clinical trial; 2. Patients with significantly abnormal coagulation function; 3. Patients with obvious infectious lesions on the proposed puncture path; 4. Patients with a large amount of pleural effusion or peritoneal effusion; 5. Pregnant or lactating women; 6. Patients with cognitive dysfunction; 7. Patients assessed by the researchers as having poor cooperation for this trial; 8. Patients who have participated in other clinical trials or studies within 3 months, and the researchers believe that this may have an impact on this trial; 9. Patients for whom the researchers consider other circumstances not suitable for participating in this clinical trial.

Design outcomes

Primary

MeasureTime frame
The success rate of positioning when the number of puncture adjustments is <= 2;

Secondary

MeasureTime frame
The success rate of positioning when the number of puncture adjustments is no more than 1 time;The total number of CT scans conducted when the puncture positioning was successful;The number of needle adjustments during the puncture process;Positional accuracy;Puncture time;Evaluation of the performance of equipment usage;

Countries

China

Contacts

Public ContactJiayuan Sun

Shanghai Chest Hospital

jysun1976@163.com+86 180 1732 1598

Outcome results

None listed

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