Uterine MyomaNCT06658145
Safety and Efficacy of Using a Novel Full Visual Access Platform System in Transvaginal Hysterectomy
A study testing Vnotes surgery using fully visualised surgical instruments and Vnotes surgery using traditional surgical instruments in people with Uterine Myoma and Surgery, Laparoscopic, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 60 years, women only
- Conditions the study is for
- Uterine Myoma, Surgery, Laparoscopic
- What is being tested?
- Vnotes surgery using fully visualised surgical instruments and Vnotes surgery using traditional surgical instruments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Feb 2025to Jun 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
China-Japan Friendship Hospital
Beijing, Beijing Municipality, 086010
Fang Zhao, MD, +86-010-84206115, jacyliang@sina.com
About this study
Official title: The Establishment and Clinical Study of the Whole Visual VNOTES Approach Platform
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.
Read the detailed description
A multi-center prospective randomized controlled trial was conducted to evaluate the efficacy and safety of the vNOTES technique in patients with uterine fibroids who were scheduled for total hysterectomy. The patients were randomly assigned to the vNOTES group (experimental group) and the traditional vNOTES group (control group). The access platform was established using a visualization method or the traditional laparoscopic method, and the surgical operation was completed. The time required to establish the platform, the amount of bleeding, the total surgical time, the anesthesia indicators, complications, and follow-up indicators were recorded, and the effectiveness and safety of the technique were evaluated.
- Conditions
- Uterine Myoma, Surgery, Laparoscopic
- Being tested
- Vnotes surgery using fully visualised surgical instruments, Vnotes surgery using traditional surgical instruments
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vnotes surgery using fully visualised surgical instrumentsDevice
Vnotes surgery using fully visualised surgical instruments
Vnotes surgery using traditional surgical instrumentsDevice
Vnotes surgery using traditional surgical instruments
| Study group | Role | What they receive |
|---|---|---|
| Full visibility vnotes group | Experimental | A suitable size of multi-channel vaginal sealing instrument was inserted from the vagina, pneumoperitoneum formed air pressure, and the vaginal dome was dilated and fully exposed. The dome was opened under laparoscopy, and an approach platform was established to complete the total hysterectomy. Receives: Device: Vnotes surgery using fully visualised surgical instruments |
| Traditional vnotes group | Experimental | The vaginal fornix and part of cervical ligaments were incised by vaginal operation, and an approach platform was established to complete hysterectomy. Receives: Device: Vnotes surgery using traditional surgical instruments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of access platform establishment
Success is defined as opening the vaginal vault and entering the abdominal cavity to create stable abdominal pressure
Measured: End of surgery
Secondary outcomes (13)
Tightness of equipment
Throughout the operation, whether the device can remain airtight
Measured: End of surgery
Stability of equipment
Throughout the operation, whether the equipment is tilted or slipped
Measured: End of surgery
Controllability of equipment
Throughout the operation, whether the equipment can be smoothly inserted, extended, conformed, and advanced
Measured: End of surgery
Time of establishment of the access platform
The time from the start of the procedure to the establishment of vaginal access
Measured: End of surgery
Total time of surgery
The time from the beginning of the procedure to its complete completion
Measured: End of surgery
Total surgical bleeding volume
Total blood loss from the beginning to the end of the procedure
Measured: End of surgery
The amount of bleeding during the process of establishing the platform
The amount of bleeding from the beginning of surgery until the establishment of vaginal access
Measured: End of surgery
Surgical complications
Whether there was fever, infection and organ damage after operation
Measured: 6 months after surgery
Length of hospital stay
The time from admission to discharge
Measured: 6 months after surgery
Pain VAS score
Pain scores during postoperative hospital stay and follow-up（The Visual Analogue Scale (VAS) is a widely used method for pain assessment. 0 represents "no pain" and 10 represents "most severe pain".）
Measured: 6 months after surgery
The Patients' life quality postoperative
The Patients' life quality postoperative be measured by Questionnaire.
Measured: 6 months after surgery
Heart rate during surgery
The magnitude of the change in the surgical center rate
Measured: End of surgery
blood pressure during surgery
The magnitude of the change in blood pressure during surgery
Measured: End of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study startFeb 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine MyomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 94 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Liang, China-Japan Friendship Hospital
- Investigators
- Jing Liang, MD, Principal investigator, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658145
- Sponsor's protocol ID
- NTCS-vnotesLH
- Status last verified
- Oct 2024
- First submitted
- 10 Sep 2024
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No