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Evaluation of the safety and effectiveness of the Jingfeng Single-Port Laparoscopic Surgery System (SP1000) compared to the Jingfeng Thoracoabdominal Laparoscopic Surgery System (MP1000) in a single-center, randomized, single-blind, parallel-controlled clinical study

Evaluation of the safety and effectiveness of the Jingfeng Single-Port Laparoscopic Surgery System (SP1000) compared to the Jingfeng Thoracoabdominal Laparoscopic Surgery System (MP1000) in a single-center, randomized, single-blind, parallel-controlled clinical study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500104467
Enrollment
Unknown
Registered
2025-06-18
Start date
2025-06-23
Completion date
Unknown
Last updated
2025-06-24

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

Conditions

Prostate cancer

Interventions

Jingfeng Single-Port Laparoscopic Surgery System (SP1000) :Jingfeng Single-Port Laparoscopic Surgery System (SP1000)
Jingfeng Abdominal Laparoscopic Surgery System (MP1000) :Jingfeng Abdominal Laparoscopic Surgery System (MP1000)

Sponsors

The First Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 18-80 years old, male; 2.BMI:18-30Kg/m^2; 3. Patients with prostate cancer who have undergone radical prostatectomy with clinical stage <=T2bN0M0 and patients with low- and intermediate-risk prostate cancer; 4. Those whose physiological condition can undergo laparoscopic surgery; 5. Willing to cooperate with and complete the study follow-up and related examinations; 6. Those who voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have severe cardiovascular or circulatory disease and cannot tolerate surgery; 2. Pregnancy or lactation; 3. Have a history of epilepsy or psychiatric illness that is uncontrollable; 4. Have a history of surgery at the relevant surgical location; 5. Severe allergies and suspected or confirmed alcohol or drug addicts; 6. Intra-abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic disease; 7. Inability to understand the study requirements, or unable to complete the study follow-up plan; 8. Those who are considered by the investigator to be inappropriate to participate in this study (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
Achievement ratio of operation;

Secondary

MeasureTime frame
Time of operation;The duration of the main surgical procedure;Estimated blood loss during operation;Positive rate of surgical margins;Patient's pain score;Doctor's satisfaction;Postoperative urinary control rate;Hospital stay;Drainage time;Postoperative ventilation time;Satisfaction with scar;Readmission rate;Reoperation rate;Mortality rate;

Countries

China

Contacts

Public ContactLiang Chaozhao

The First Affiliated Hospital of Anhui Medical University

liang_chaozhao@ahmu.edu.cn+86 135 0560 4595

Outcome results

None listed

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