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Clinical Trials in China / NCT06828419
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A Clinical Study on the Feasibility and Safety of Abdominal Endoscopic Single-port Surgery System to Assist Gynecological Day Surgery

NCT06828419 · tracked via the Priya Life Science China tracker
Sponsor
Second Affiliated Hospital of Wenzhou Medical University
Phase
Not applicable
Started
2025-04-10
Last updated
2025-04-03

Condition(s) studied

AdenopathyUterine FibroidsOvarian CystsAdnexal MassOvarian DiseasesAdnexal CystAdnexal Diseases

Investigational drug(s) / intervention(s)

Domestic single-port laparoscopic surgery system

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。

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. Women aged 18 to 75 years old, with a body mass index (BMI) of no more than 32 kg/m2; 2. Conscious, no history of mental illness, accompanied by an adult during the perioperative period; 3. Educate the subjects, who are willing to undergo day surgery, understand and accept the surgical method and anesthesia method; 4. Subjects and families understand perioperative care and are willing and able to complete post-discharge care; 5. Elective surgery, no serious complications affecting the operation and prognosis, aCCI age adjusted comorbidity index 0 points; 6. According to the adhesion risk scoring system of European Anti-Adhesions in Gynaecology Expert Panel (ANGEL), the adhesion risk was divided into three levels: high, medium and low. Subjects with low risk (0 to 12 points) and abdominal wall scarring and pelvic cavity B-ultrasonography do not indicate obvious pelvic cavity adhesion wiil be included. Exclusion Criteria: 1. Moderate and high-risk patients will be excluded based on ANGEL adhesion risk scoring system; 2. Subjects with hemorrhagic rupture of ectopic pregnancy and unstable vital signs; 3. Genital tract infection or in the acute phase of systemic infection; 4. Subjects on long-term anticoagulant therapy or with coagulation dysfunction; 5. Subjects have severe heart and lung disease, liver and kidney dysfunction, and cannot tolerate anesthesia; 6. A history of abdominal or diaphragmatic hernia, abnormal umbilical cord development, or umbilical surgery; 7. Not willing to undergo endoscopic surgery; 8. Participated in other drug and device clinical trials within 3 months before surgery.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Second Affiliated Hospital of Wenzhou Medical University Wenzhou Zhejiang

More Second Affiliated Hospital of Wenzhou Medical University trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06828419 on ClinicalTrials.gov ↗ ← All trials in China