Actively Recruiting
Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
Led by Universitaire Ziekenhuizen KU Leuven · Updated on 2025-03-14
82
Participants Needed
4
Research Sites
108 weeks
Total Duration
On this page
Sponsors
U
Universitaire Ziekenhuizen KU Leuven
Lead Sponsor
A
Amsterdam UMC, location VUmc
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Temporary Artery Clipping for Robotically-assisted Myomectomy, a Multicentric Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent given before screening
- Use of highly effective birth control methods (implants, injectables, certain IUDs, combined oral contraceptives, true sexual abstinence, or vasectomized partner)
- Female gender
- Age between 18 and 50 years
- Presence of myomas eligible for myomectomy, excluding FIGO 7-8 myomas
You will not qualify if you...
- Any disorder that may risk participant safety or compliance
- Prior or concurrent treatments that may compromise safety or study integrity
- Participation in another interventional trial with investigational medicinal product or device
- Refusal to participate in the trial
- Known or suspected malignancy
- Contraindication for laparoscopic or robotic surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
University Hospitals Leuven
Leuven, Belgium, 3000
Actively Recruiting
2
Department of Gynecology and Obstetrics, Hopital Bichat
Paris, France
Not Yet Recruiting
3
Service de gynécologie, Centre Hospitalier Universitaire de Rennes
Rennes, France
Not Yet Recruiting
4
Amsterdam UMC, locatie VUmc
Amsterdam, Netherlands
Not Yet Recruiting
Research Team
S
Stefan Timmerman, MD
CONTACT
W
Wouter Froyman, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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