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 range30 Years – 50 Years

SexFEMALE

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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.
✕. Patient had been treated with GnRH over the last 3 months.
✕. Patient has known symptomatic endometriosis that cannot be completely removed during laparoscopic procedure.
✕. Patient has known or suspected adenomyosis
✕. Patient had any active abdominal/pelvic inflammatory disease.
✕. Patient has known or suspected gynecologic malignancy.
✕. Patient with submucosal fibroids type "zero"

What they're measuring

Improvement in patient's fibroid-related quality of life

Timeframe: 12 months

Incidence, subsequent interventions and procedure-related adverse events

Timeframe: 12 months

Trial details

NCT IDNCT01735812

SponsorIceCure Medical Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-12

View on ClinicalTrials.gov More Symptomatic Uterine Fibroids trials