RecruitingNot ApplicableNCT06658145

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


Sponsor

China-Japan Friendship Hospital

Enrollment

94 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

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: FEMALEMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates a new surgical platform that gives surgeons a clearer view during vaginal hysterectomy (removal of the uterus through the vagina) in women with uterine fibroids. The aim is to see whether this new tool makes the surgery safer and easier. **You may be eligible if...** - You are a woman aged 60 or younger - You need a total hysterectomy because of uterine fibroids - Your BMI is between 18.5 and 27.9 **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have never been sexually active, have vaginal abnormalities, or severe vaginal atrophy - There is any concern your condition might be cancerous - Your uterus is very large, or you have severe endometriosis, significant uterine prolapse, or history of serious pelvic infections - You have severe liver or kidney disease, a bleeding disorder, or serious heart, lung, or neurological conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEVnotes surgery using fully visualised surgical instruments

Vnotes surgery using fully visualised surgical instruments

DEVICEVnotes surgery using traditional surgical instruments

Vnotes surgery using traditional surgical instruments


Locations(1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

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NCT06658145


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