Laparoscopic Cryoablation of Uterine Fibroids (UFREEZE-01)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Symptomatic Uterine Fibroids
• Intervention / Treatment: Device: IceSense3 system

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Zrifin, Israel, 70300
    • Assaf Harofe

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in patient's fibroid-related quality of life	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.	12 months
Incidence, subsequent interventions and procedure-related adverse events	To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in fibroid volume	Reduction in fibroid volume as measured by US/MRI imaging at 6 and 12 months follow-up post treatment comparing to baseline.	12 months
Improvement in menstrual bleeding	Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment.	12 months
Improvement in patient's fibroid-related quality of life	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.	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient's and physician's overall treatment evaluation	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.	12 months
Patient blood loss	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.	12 months

Collaborators and Investigators

• Sponsor: IceCure Medical Ltd.
• Investigators: Principal Investigator: Moty Pansky, Prof., Assaf Harofe Hospital, Israel

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2012
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): December 1, 2015

Study Registration Dates

• First Submitted: November 26, 2012
• First Submitted That Met QC Criteria: November 27, 2012
• First Posted (ESTIMATE): November 28, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 13, 2022
• Last Update Submitted That Met QC Criteria: June 9, 2022
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Keywords: cryoablation; uterine fibroid; uterine myoma; who completed her family planning; but wishes to preserve her uterus
• Additional Relevant MeSH Terms: Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Connective Tissue Diseases; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Leiomyoma; Myofibroma
• Other Study ID Numbers: ICUFL-01