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Clinical Study on the Safety and Efficacy of the Laparoscopic Single-Port Surgery System in Gynecological Surgeries

Clinical Study on the Safety and Efficacy of the Laparoscopic Single-Port Surgery System in Gynecological Surgeries

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500100736
Enrollment
Unknown
Registered
2025-04-14
Start date
2025-04-15
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Benign and Malignant Gynecological Diseases

Interventions

Group of Single-port Gynecological Robot:Gynecological surgeries using the laparoscopic single-port surgery system

Sponsors

International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Subjects who can undergo elective surgery and can tolerate surgery and anesthesia; 2. Subjects with no history of complex gynecological diseases and no serious medical and surgical diseases; 3. Subjects with no history of mental illness; 4. Subjects who meet the indications for gynecological surgery; 5. Study participants who agree to conduct the study, have good compliance, and voluntarily sign the informed consent form

Exclusion criteria

Exclusion criteria: 1. Have a history of pelvic and abdominal surgery, and consider severe pelvic adhesions; 2. Patients with ruptured ectopic pregnancy and massive bleeding and unstable vital signs; 3. Patients in the genital tract or in the acute phase of systemic infection; 4. Long-term anticoagulant drug treatment or coagulation dysfunction; 5. Patients with severe heart and lung diseases, liver and kidney insufficiency, and unable to tolerate anesthesia; 6. Patients with abdominal wall hernia or diaphragmatic hernia, abnormal development of the umbilicus and a history of surgery; 7. Subjects who are unwilling to undergo laparoscopic surgery; 8. Subjects who have participated in other drug and device clinical studies within 3 months prior to surgery. 9. Other circumstances that the investigator considers inappropriate to participate in this study.

Design outcomes

Primary

MeasureTime frame
Surgical success rate;

Secondary

MeasureTime frame
surgery time;Intraoperative bleeding;hospital stay;Doctor Satisfaction Questionnaire;

Countries

China

Contacts

Public ContactJian Zhang

International Peace Maternity and Child Health Hospital affiliated to Shanghai Jiao Tong University School of Medicine

ipmch@foxmail.com+86 21 64070434

Outcome results

None listed

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