NCT06658145

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

The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 94 (estimated)
• Sponsor: China-Japan Friendship Hospital · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A multi-center prospective randomized controlled trial was conducted to evaluate the efficacy and safety of the vNOTES technique in patients with uterine fibroids who were scheduled for total hysterectomy. The patients were randomly assigned to the vNOTES group (experimental group) and the traditional vNOTES group (control group). The access platform was established using a visualization method or the traditional laparoscopic method, and the surgical operation was completed. The time required to establish the platform, the amount of bleeding, the total surgical time, the anesthesia indicators, complications, and follow-up indicators were recorded, and the effectiveness and safety of the technique were evaluated.

Conditions

• Uterine Myoma
• Surgery, Laparoscopic

Interventions

Type	Name	Description
DEVICE	Vnotes surgery using fully visualised surgical instruments	Vnotes surgery using fully visualised surgical instruments
DEVICE	Vnotes surgery using traditional surgical instruments	Vnotes surgery using traditional surgical instruments

Timeline

• Start date: 2025-02-01
• Primary completion: 2026-12-31
• Completion: 2027-06-01
• First posted: 2024-10-26
• Last updated: 2025-02-12

Locations

1 site across 1 country: China