Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
China-Japan Friendship Hospital
Beijing, Beijing Municipality, China, 086010
Actively Recruiting
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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