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Recruiting NCT06658145

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

Trial Parameters

Condition Uterine Myoma
Sponsor China-Japan Friendship Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 94
Sex FEMALE
Min Age N/A
Max Age 60 Years
Start Date 2025-02
Completion 2026-12-31
Interventions
Vnotes surgery using fully visualised surgical instrumentsVnotes surgery using traditional surgical instruments

Brief 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 Criteria

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 si

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