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Clinical trial on the safety and effectiveness of robot assisted abdominal and pelvic surgery using the abdominal endoscopic surgical system (SA-1000)

Clinical trial on the safety and effectiveness of robot assisted abdominal and pelvic surgery using the abdominal endoscopic surgical system (SA-1000)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107401
Enrollment
Unknown
Registered
2025-08-11
Start date
2022-11-10
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Gallbladder stones, Cholecystitis, Benign gallbladder polyps, Renal cysts, Adrenal adenoma, Hysteromyoma, Benign uterine diseases

Interventions

treatment group:Endoscopic surgical procedure

Sponsors

Beijing Friendship Hospital ,Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1.18 years old<= age <= 80 years old; 2.Patients who require abdominal and pelvic endoscopic surgery, including but not limited to the following procedures: (1). General Surgery: Cholecystectomy; (2). Urology: Adrenal tumor resection, renal cyst resection; (3). Gynecology: Hysterectomy; 3.acceptable for laparoscopic surgery; 4.Willing to cooperate and complete research follow-up and related examinations; 5.The subjects or their representatives voluntarily participate in this trial and sign a written informed consent form.

Exclusion criteria

Exclusion criteria: 1. Pregnant or lactating women; 2. Patients with malignant tumors clinically classified as stage IV; 3. Those who require emergency surgery; 4. There is active bleeding, abnormal coagulation function (prothrombin time (PT) or international normalized ratio (INR) 1.5 times higher than the upper limit of normal), or platelet count<80 × 10^9/L; 5. Patients with severe cardiovascular or circulatory system diseases who cannot tolerate surgery; 6. Participated in other clinical trials within the past month; 7. Unable to understand the experimental requirements or unable to complete the study follow-up plan; 8. Researchers believe that there are other situations that are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Success rat;

Secondary

MeasureTime frame
blood loss;Postoperative hospitalization days;incision;Postoperative pain score;Physiological load assessment;Psychological load assessment;Occurrence rate of serious equipment malfunctions;The occurrence of repairable equipment malfunctions;Evaluation of Equipment Performance;AE/SAE;Equipment defect incidence rate;

Countries

China

Contacts

Public ContactZhang Zhongtao

Beijing Friendship Hospital ,Capital Medical University

zhangzht@ccmu.edu.cn+86 10 63138217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 31, 2026