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Clinical Trials in China / NCT06658145
Recruiting Not applicable

Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy

NCT06658145 · tracked via the Priya Life Science China tracker
Sponsor
China-Japan Friendship Hospital
Phase
Not applicable
Started
2025-02
Last updated
2025-02-12

Condition(s) studied

Uterine MyomaSurgery, Laparoscopic

Investigational drug(s) / intervention(s)

Vnotes surgery using fully visualised surgical instrumentsVnotes surgery using traditional surgical instruments

Vnotes surgery using fully visualised surgical instruments: Vnotes surgery using fully visualised surgical instruments

Vnotes surgery using traditional surgical instruments: Vnotes surgery using traditional surgical instruments

Study summary

The modified vNOTES hysterectomy was accomplished and validated for efficacy and safety using a multi-access vaginal confinement instrument with a fully visualised vaginal access platform.

Eligibility

Sex
FEMALE
Min age
—
Max age
60 Years
Healthy volunteers
No
Inclusion Criteria: 1. Female patients ≤ 60years old 2. Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids 3. BMI ranges from 18.5 to 27.9kg/m2; 4. Informed consent signed by the subject himself or his legal representative. Exclusion Criteria: 1. Pregnant and lactating women; 2. asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis; 3. Preoperative examination for malignant possibility 4. Uterine volume ≥20 weeks, history of pelvic inflammatory disease, severe endometriosis, degree III or IV uterine prolapse; Previous surgical history of intestinal obstruction, recurrent pelvic inflammatory disease, pelvic tuberculosis, and pelvic abdominal tumor; Gynecological examination of the uterine and rectal fossa is completely closed; 5. Patients known to have severe hepatic or renal dysfunction; 6. Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity; 7. complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, Cushing\'s syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders; 8. patients with acute infection; 9. Known to have participated in any other clinical trial or taken hormone therapy within 3 months; 10. who cannot sign the informed consent; 11. For those with known or suspected poor compliance who could not complete the trial.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
China-Japan Friendship Hospital Beijing Beijing Municipality Recruiting

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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 NCT06658145 on ClinicalTrials.gov ↗ ← All trials in China