Laparoscopic Cryoablation of Uterine Fibroids (NCT01735812) | Clinical Trial Compass
WithdrawnNot Applicable
Laparoscopic Cryoablation of Uterine Fibroids
Israel0Started 2012-12
Plain-language summary
The goal of this study is to evaluate the safety \& efficacy of cryoablation using IceCure medical's IceSense3™ device for the treatment of symptomatic uterine fibroids in a percutaneous lap-assisted approach.
Who can participate
Age range
30 Years – 50 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Pre-menopausal woman between the ages of 30 and 50 (inclusive)
. Patient had completed her family planning and does not desire future childbearing.
. Patient is suffering from menorrhagia as a result of symptomatic uterine fibroids.
. Patient's uterus size is smaller than 18 gestational weeks.
. Patient wishes to preserve her uterus and avoid hysterectomy.
. Patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by US/MRI.
. Overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523)
. Patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment.
Exclusion criteria
. Patient had not finished her family planning
. Patient was already treated for uterine fibroids in the past (UAE, myomectomy, HIFU,…) or undergone endometrial ablation.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement in patient's fibroid-related quality of life
Timeframe: 12 months
2
Incidence, subsequent interventions and procedure-related adverse events