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
Inclusion Criteria4
- Female patients ≤ 60years old
- Patients requiring total hysterectomy (with or without bilateral adjuncts or salpingectomy) due to uterine fibroids
- BMI ranges from 18.5 to 27.9kg/m2;
- Informed consent signed by the subject himself or his legal representative.
Exclusion Criteria11
- Pregnant and lactating women;
- asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
- Preoperative examination for malignant possibility
- 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;
- Patients known to have severe hepatic or renal dysfunction;
- Patients with known blood disorders, coagulation disorders, active bleeding at any site, or bleeding propensity;
- complicated with serious diseases of central nervous system, cardiovascular system, liver and kidney, digestive tract, respiratory system, endocrine and metabolism (thyroid disease, Cushing\'s syndrome, hyperprolactinemia), skeletal and muscular system and mental disorders;
- patients with acute infection;
- Known to have participated in any other clinical trial or taken hormone therapy within 3 months;
- who cannot sign the informed consent;
- For those with known or suspected poor compliance who could not complete the trial.
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)
View Full Details on ClinicalTrials.gov
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NCT06658145