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A multi-center, randomized, single-blind, parallel controlled clinical study on the safety and effectiveness of Jingfeng Laparoscopic Surgical System (MP1000) versus Da Vinci Endoscopic Surgical Control System (IS 4000/IS3000)

A multi-center, randomized, single-blind, parallel controlled clinical study on the safety and effectiveness of Jingfeng Laparoscopic Surgical System (MP1000) versus Da Vinci Endoscopic Surgical Control System (IS 4000/IS3000)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300070744
Enrollment
Unknown
Registered
2023-04-21
Start date
2023-04-17
Completion date
Unknown
Last updated
2023-06-04

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

Conditions

Urological diseases

Interventions

test group:Surgical treatment with Jingfeng laparoscopic surgery system (MP1000)
control group:Surgical treatment with da Vinci endoscopic surgical control system (IS 4000/IS3000)

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1), 18-80 years old, male or female; 2), BMI: 18-30Kg/m2; 3), Prostate cancer patients with radical prostatectomy, clinical stage = T2bN0M0, low-to-medium risk prostate cancer patients, patients with renal tumors = 4cm who underwent partial nephrectomy; 4), physiological conditions acceptable for laparoscopic surgery; 5), willing to cooperate and complete the research follow-up and related inspections; 6), those who voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1), have severe cardiovascular or circulatory diseases and cannot tolerate surgery; 2), are pregnant or breastfeeding; 3), have a history of epilepsy or mental illness and cannot control it; 4), had a history of surgery at the relevant surgical site; 5), severe allergic constitution and suspected or confirmed alcohol or drug addiction; 6), abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic disease; 7), unable to understand the research requirements, or unable to complete the study follow-up plan; 8), participated in other clinical researchers within 90 days; 9), the researcher thinks it is not suitable to participate in this research (such as the subject is unwilling to accept the research plan, the expected value is unrealistic or has obvious emotional problems, etc.).

Design outcomes

Primary

MeasureTime frame
Rate of conversion to open surgery, conversion rate to laparoscopy;

Secondary

MeasureTime frame
operation time; Intraoperative blood loss;complication rate;Positive margin rate;Drainage volume, drainage tube retention time;Proportion of urinary continence immediately after prostate cancer surgery;doctor satisfaction;

Countries

China

Contacts

Public ContactZhaozhao Liang

The First Affiliated Hospital of Anhui Medical University

taishengwk@163.com+86 18355159268

Outcome results

None listed

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