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The prospective, multicenter, randomized, parallel-controlled clinical trial to assess the effectiveness and safety of a multi-loop feedback interventional surgical control system

The prospective, multicenter, randomized, parallel-controlled clinical trial to assess the effectiveness and safety of a multi-loop feedback interventional surgical control system

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075512
Enrollment
Unknown
Registered
2023-09-07
Start date
2023-09-10
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Various liver diseases requiring biopsy or ablation

Interventions

Control Group:CT-guided percutaneous puncture
Experimental Group:Using a multi-loop feedback puncture intervention surgical control system for percutaneous puncture under CT guidance

Sponsors

Lishui Municipal Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Participants must be 18 years of age or older, with no gender restrictions. (2) Participants must be clinically assessed and deemed in need of a liver lesion puncture by the researcher. (3) Liver lesions with a diameter greater than or equal to 1 cm are eligible for inclusion. (4) Participants must have liver function graded as either Child-Pugh Class A or Class B. (5) Participants must voluntarily agree to participate in this clinical trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Individuals with severe liver cirrhosis or in a decompensated liver function state within the 3 months prior to screening and who have undergone abdominal paracentesis for the treatment of a large amount of ascites. (2) Individuals with severe coagulation disorders during the screening period, characterized by a platelet count 6s, and an international normalized ratio (INR) > 1.5. (3) Individuals classified as NYHA heart function Grade III and IV during the screening period. (4) Individuals with severe chronic obstructive pulmonary disease (COPD) or severe asthma during the screening period. (5) Individuals with renal insufficiency during the screening period, defined by creatinine (Cr) or blood urea nitrogen (BUN/UREA) levels exceeding two times the upper limit of normal. (6) Individuals who are unable to cooperate with surgical positioning and other requirements for surgery. (7) Pregnant or lactating women of childbearing age and other vulnerable groups. (8) Individuals who have participated in other interventional clinical trials within the month prior to the commencement of this trial. (9) Other individuals who are deemed unsuitable for participation in this trial by the investigator.

Design outcomes

Primary

MeasureTime frame
First attempt success rate;

Secondary

MeasureTime frame
Localization puncture success rate;Number of puncture attempts;Puncture accuracy;Puncture surgery planning time;Instrument performance evaluation;

Countries

China

Contacts

Public ContactJiansong Ji

Lishui Municipal Central Hospital

jjstcty@sina.com+86 578 228 5888

Outcome results

None listed

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