NCT06269809 Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
| NCT ID | NCT06269809 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Universitaire Ziekenhuizen KU Leuven |
| Condition | Fibroid Uterus |
| Study Type | INTERVENTIONAL |
| Enrollment | 82 participants |
| Start Date | 2023-05-04 |
| Primary Completion | 2025-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 82 participants in total. It began in 2023-05-04 with a primary completion date of 2025-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This study aims to investigate the efficacy of temporary clipping of the uterine artery and utero-ovarian ligament during robotically assisted myomectomy (RAM) for uterine fibroids. While RAM is increasingly used for myomectomy, bleeding control remains challenging. Temporary clipping of arteries has shown promise in conventional laparoscopy but has not been studied in RAM. This randomized controlled trial will assess primary endpoints such as estimated blood loss, need for transfusion, and hemoglobin drop, alongside secondary outcomes like complication rates and operation time.
Eligibility Criteria
Inclusion Criteria: Participants eligible for inclusion in this Trial must meet all of the following criteria: 1. Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures 2. Use of highly effective methods of birth control; defined as those that, alone or in combination, result in low failure rate (i.e., less than 1% per year) when used consistently and correctly; such as implants, injectables, combined oral contraceptives, some IUDs, true sexual abstinence (i.e. refraining from heterosexual intercourse during the entire period of risk associated with the Trial treatment(s)) or commitment to a vasectomised partner. 3. Female 4. Age: 18-50 years 5. Myomas, eligible for myomectomy, with the exclusion of FIGO 7-8 myomas. Exclusion Criteria: Participants eligible for this Trial must not meet any of the following criteria: 1. Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol 2. Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial 3. Participation in an interventional Trial with an investigational medicinal product (IMP) or device 4. Patient refusal to participate in the Trial 5. (Possible) malignancy 6. any contra indication for a laparoscopic or robotic surgery
Contact & Investigator
Wouter Froyman, MD, PhD
PRINCIPAL INVESTIGATOR
Universitaire Ziekenhuizen KU Leuven
Frequently Asked Questions
Who can join the NCT06269809 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Fibroid Uterus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06269809 currently recruiting?
Yes, NCT06269809 is actively recruiting participants. Contact the research team at stefan.timmerman@uzleuven.be for enrollment information.
Where is the NCT06269809 trial being conducted?
This trial is being conducted at Leuven, Belgium, Paris, France, Rennes, France, Amsterdam, Netherlands.
Who is sponsoring the NCT06269809 clinical trial?
NCT06269809 is sponsored by Universitaire Ziekenhuizen KU Leuven. The principal investigator is Wouter Froyman, MD, PhD at Universitaire Ziekenhuizen KU Leuven. The trial plans to enroll 82 participants.