NCT06828419

A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 63 (estimated)
• Sponsor: Second Affiliated Hospital of Wenzhou Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

In this study, a prospective study is used to select patients who will undergo intra-abdominal endoscopic single-port surgery system for benign gynecological diseases from February 2025 to December 2026 in the Second Affiliated Hospital of Wenzhou Medical University, including hysterectomy, myomectomy, ovarian cyst removal and adnexectomy. The study will perform statistical analysis to evaluate the feasibility and the main factors affecting the safety of intra-abdominal endoscopic single-port surgery system(SR-ENS-600) used in gynecological day surgery.

Conditions

• Adenopathy
• Uterine Fibroids
• Ovarian Cysts
• Adnexal Mass
• Ovarian Diseases
• Adnexal Cyst
• Adnexal Diseases

Interventions

Type	Name	Description
DEVICE	Domestic single-port laparoscopic surgery system	The minimum distance of the single-port surgical system from the port is 5-7cm to obtain the instrument bending space. The load capacity of surgical tools is increased from 2N to 5N, which greatly improves the structural reliability. At the same time, it can realize 6 degrees of freedom movement。

Timeline

• Start date: 2025-04-10
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-02-14
• Last updated: 2025-04-03

Locations

1 site across 1 country: China