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NCT06658145Recruiting

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

Source: ClinicalTrials.gov · Last updated 12 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
94 (estimated)
First submitted
10 Sept 2024
Start date
Feb 2025
Primary completion date
31 Dec 2026
Lead sponsor
China-Japan Friendship Hospital
NCT number
NCT06658145

What you commit to

  • Study type: Interventional
  • Planned participants: 94
  • From Feb 2025 to the primary completion date, 31 Dec 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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;
  • Known to have participated in any other clinical trial or taken hormone therapy within 3 months;

Other illness

  • Preoperative examination for malignant possibility
  • 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;

Other

  • Pregnant and lactating women;
  • asexual life history, vaginal malformations or adhesions, postmenopausal vaginal atrophy and stenosis;
  • Patients known to have severe hepatic or renal dysfunction;
  • who cannot sign the informed consent;
  • For those with known or suspected poor compliance who could not complete the trial.

Who the study is looking for

  • 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.

Age in the registry: - to 60 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
China-Japan Friendship Hospital
Coordinator of this site? Confirm its status
BeijingChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.