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

Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Study ID
NCT06828419
Status
Not Yet Recruiting

Notify me when recruiting opens

Save your spot on the interest list for this study. We'll keep your details with this study so our team can follow up when recruiting opens.

Not yet recruiting

Add your contact details and location so we can keep your interest tied to this study.

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Domestic single-port laparoscopic surgery system — DEVICE
    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。

Study Details

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.

Key Dates

Start date
Apr 10, 2025
Status verified
Mar 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
63 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Other: Domestic single-port laparoscopic surgery system group
    The domestic single-port robotic laparoscopic surgery system is a new minimally invasive surgical method. Compared with traditional laparoscopic surgery, it establishes the surgical approach through the natural scar umbilicus of the human body, thus bringing less trauma and beautiful experience to patients

Primary Outcome Measure

Day Surgery Success Rate [ Time Frame: Patient recruitment ends and all patients complete surgery, up to 2 years ]

Central Contacts

Related Studies