Clinical trial NCT01735812: Laparoscopic Cryoablation of Uterine Fibroids
Official title: Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Symptomatic Uterine Fibroids
Keywords: cryoablation
uterine fibroid
uterine myoma
who completed her family planning
but wishes to preserve her uterus
Lead sponsor: IceCure Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-11-28
Enrollment: 0
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Pre-menopausal woman between the ages of 30 and 50 (inclusive)
2. Patient had completed her family planning and does not desire future childbearing.
3. Patient is suffering from menorrhagia as a result of symptomatic uterine fibroids.
4. Patient's uterus size is smaller than 18 gestational weeks.
5. Patient wishes to preserve her uterus and avoid hysterectomy.
6. Patient has 1-3 treatable uterine fibroids in size of up to 10cm measured by US/MRI.
7. Overall treated fibroid volume is ≤ 3,138cm3 (width x length x height x 0.523)
8. Patient has clinical menorrhagia as indicated by menstrual blood loss of ≥160 ml during one baseline cycle prior to treatment.
9. Patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment.
10. The patient has been informed of the study and agrees to its provisions, and has signed an IRB approved written informed consent, including data privacy authorization.

Exclusion Criteria:

1. Patient had not finished her family planning
2. Patient was already treated for uterine fibroids in the past (UAE, myomectomy, HIFU,...) or undergone endometrial ablation.
3. Patient had been treated with GnRH over the last 3 months.
4. Patient has known symptomatic endometriosis that cannot be completely removed during laparoscopic procedure.
5. Patient has known or suspected adenomyosis
6. Patient had any active abdominal/pelvic inflammatory disease.
7. Patient has known or suspected gynecologic malignancy.
8. Patient with submucosal fibroids type "zero"
9. Patient with undiagnosed vaginal bleeding
10. Patient with blood clotting disorders
11. Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
12. Patient participating in other trials using drugs or devices.
13. Patient is unable to commit all study requirements including follow-up visits and questionnaires.
14. Patient has any contraindication for laparoscopic surgery

Primary outcomes:
measure: Improvement in patient's fibroid-related quality of life
timeFrame: 12 months
measure: Incidence, subsequent interventions and procedure-related adverse events
timeFrame: 12 months
Secondary outcomes:
measure: Reduction in fibroid volume
timeFrame: 12 months
measure: Improvement in menstrual bleeding
timeFrame: 12 months
measure: Improvement in patient's fibroid-related quality of life
timeFrame: 6 months
Other outcomes:
measure: Patient's and physician's overall treatment evaluation
timeFrame: 12 months
measure: Patient blood loss
timeFrame: 12 months
Locations:
city: Zrifin
country: Israel
facility: Assaf Harofe
Study officials:
affiliation: Assaf Harofe Hospital, Israel
name: Moty Pansky, Prof.
role: PRINCIPAL_INVESTIGATOR
References: