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Prospective, multicenter, single-group, target-value clinical trial to evaluate the safety and efficacy of the Endoscopic surgical instrument Control System (SP1000)

Prospective, multicenter, single-group, target-value clinical trial to evaluate the safety and efficacy of the Endoscopic surgical instrument Control System (SP1000)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300067956
Enrollment
Unknown
Registered
2023-02-01
Start date
2022-02-28
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

gynecologic diseases

Interventions

Experimental group:Endoscopic surgical Instrument Control System (SP1000)

Sponsors

the PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1. 18-85 years old, female; 2. BMI18-30Kg/m2; 3. There are related indications of gynecological surgery; 4. Patients with physiological conditions acceptable for laparoscopic surgery; 5. Willing to cooperate and complete the study follow-up and related examinations; 6. Those who voluntarily sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. have serious cardiovascular or circulatory diseases and cannot tolerate surgery; 2. pregnancy or lactation; 3. have a history of epilepsy or mental illness; 4. Previous surgical history at the relevant surgical site; 5. People with severe allergies and suspected or confirmed alcohol or drug addiction; 6. Abdominal/pelvic infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastatic disease; 7. Unable to understand the requirements of the study or unable to complete the study follow-up plan; 8. Participants in other surgical trials within 90 days; 9. The researcher considers that the subjects are not suitable to participate in the study (for example, the subjects are unwilling to accept the study plan, their expectations are unrealistic, or they have obvious emotional problems, etc.).

Design outcomes

Primary

MeasureTime frame
Surgical success rate;

Secondary

MeasureTime frame
Incidence of perioperative complications;The installation time;The operation time;Intraoperative blood loss;Margin positive rate;Postoperative pain;Doctor satisfaction;Postoperative hospital stay;Scar satisfaction;

Countries

China

Contacts

Public ContactYuanguang Meng

PLA General Hospital

meng6512@vip.sina.com+86 13501093681

Outcome results

None listed

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