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A prospective, multicenter, single-arm clinical trial protocol to evaluate the safety and efficacy of endoscopic surgical systems for gynecological surgery

A prospective, multicenter, single-arm clinical trial protocol to evaluate the safety and efficacy of endoscopic surgical systems for gynecological surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075431
Enrollment
Unknown
Registered
2023-09-05
Start date
2023-01-05
Completion date
Unknown
Last updated
2023-09-11

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

Conditions

Gynecological surgery

Interventions

Experimental group:SHURUI endoscopic surgical robotic system

Sponsors

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Female age from 18 to 75; (2) Subjects who have elective surgery and can tolerate surgery and anesthesia; (3) Subjects who have no history of complicated gynecological diseases or serious medical and surgical diseases; (4) Subjects with no history of mental illness; (5) Subjects who meet the indications of gynecological surgery; (6) Body mass index (BMI) = 32kg/m2; (7) Subjects who agreed to conduct the study with good compliance and signed informed consent voluntarily.

Exclusion criteria

Exclusion criteria: (1) Have a history of more than twice pelvic abdominal surgeries and severe pelvic adhesions; (2) Rupture of ectopic pregnancy with massive hemorrhage and unstable vital signs; (3) Genital tract or in the acute stage of systemic infection; (4) Long-term anticoagulant therapy or coagulation dysfunction; (5) Suffering from severe heart and lung function diseases, liver and kidney insufficiency, unable to tolerate anesthesia; (6) Patients with abdominal or diaphragmatic hernia, abnormal umbilical development and surgical history; (7) Subjects who are unwilling to undergo endoscopic surgery; (8) Subjects who have participated in clinical trials of other drugs and devices within 3 months before surgery.

Design outcomes

Primary

MeasureTime frame
Surgical success rate;

Secondary

MeasureTime frame
Operation time;Blood loss;Hospital stays;Abdominal incision healing grading;Evacuation time ;Scar Cosmesis Assessment and Rating;Subject postoperative rehabilitation score;Surgeon's satisfaction socre ;

Countries

China

Contacts

Public ContactSun Dawei

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

sundw1118@aliyun.com+86 10 6915 6114

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 6, 2026