Actively Recruiting

Phase Not Applicable
Age: 0 - 60Years
FEMALE
NCT06658145

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

Led by China-Japan Friendship Hospital · Updated on 2025-02-12

94

Participants Needed

1

Research Sites

121 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 0 - 60Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Female patients 60 years old or younger
  • Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
  • Body mass index (BMI) between 18.5 and 27.9 kg/m2
  • Signed informed consent from the patient or legal representative
Not Eligible

You will not qualify if you...

  • Pregnant or lactating women
  • History of asexual life, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis
  • Suspicion or evidence of malignancy based on preoperative examination
  • Uterine volume greater than or equal to 20 weeks, history of pelvic inflammatory disease, severe endometriosis, or advanced uterine prolapse (degree III or IV)
  • Previous intestinal obstruction surgery, recurrent pelvic inflammatory disease, pelvic tuberculosis, or pelvic abdominal tumor
  • Uterine and rectal fossa completely closed on gynecological examination
  • Severe liver or kidney dysfunction
  • Known blood or coagulation disorders, active bleeding, or bleeding tendency
  • Serious diseases affecting the central nervous, cardiovascular, liver, kidney, digestive, respiratory, endocrine, musculoskeletal, or mental health
  • Acute infection
  • Participation in another clinical trial or hormone therapy within the past 3 months
  • Inability to sign informed consent
  • Poor compliance or inability to complete the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China, 086010

Actively Recruiting

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Research Team

J

Jing Liang, MD

CONTACT

Y

Yuebo Li, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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