UFREEZE-01: Laparoscopic Cryoablation of Uterine Fibroids

Sponsor

IceCure Medical Ltd. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01735812

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Symptomatic Uterine Fibroids	Device: IceSense3 system	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach

Actual Study Start Date :

Dec 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: symptomatic UF	Device: IceSense3 system The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.

Arm

Intervention/Treatment

Experimental: symptomatic UF

Device: IceSense3 system

The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.

Outcome Measures

Primary Outcome Measures

Improvement in patient's fibroid-related quality of life [12 months]
To evaluate procedural efficacy by the improvement in patient's fibroid-related quality of life as assessed in scores of symptom severity subscale questionnaire (SSS-UFS-QOL) at 12 months post-treatment comparing to baseline score.
Incidence, subsequent interventions and procedure-related adverse events [12 months]
To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment

Secondary Outcome Measures

Reduction in fibroid volume [12 months]
Reduction in fibroid volume as measured by US/MRI imaging at 6 and 12 months follow-up post treatment comparing to baseline.
Improvement in menstrual bleeding [12 months]
Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment.
Improvement in patient's fibroid-related quality of life [6 months]
Improvement in patient's fibroid-related quality of life as assessed in scores of symptom severity subscale questionnaire (SSS-UFS-QOL) at 6 months post-treatment comparing to baseline score.

Other Outcome Measures

Patient's and physician's overall treatment evaluation [12 months]
Patient's and physician's overall treatment evaluation and satisfaction will be assessed using a self-report questionnaire at 6 and 12 months post treatment.
Patient blood loss [12 months]
Patient blood loss will be also evaluated by Hemoglobin (Hb) level measurements at 6 and 12 months post treatment and will be compared to baseline.

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.
Patient is able to visit the clinic as needed during the 1 year follow-up period following the treatment.
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:

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"
Patient with undiagnosed vaginal bleeding
Patient with blood clotting disorders
Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
Patient participating in other trials using drugs or devices.
Patient is unable to commit all study requirements including follow-up visits and questionnaires.
Patient has any contraindication for laparoscopic surgery