Back to resultsLaparoscopic Cryoablation of Uterine Fibroids (UFREEZE-01)
Primary Purpose
Symptomatic Uterine Fibroids
Status
Withdrawn
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
IceSense3 system
Sponsored by
About this trial
This is an interventional treatment trial for Symptomatic Uterine Fibroids focused on measuring cryoablation, uterine fibroid, uterine myoma, who completed her family planning, but wishes to preserve her uterus
Eligibility Criteria
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
Sites / Locations
- Assaf Harofe
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
symptomatic UF
Arm Description
Outcomes
Primary Outcome Measures
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.
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
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01735812
Brief Title
Laparoscopic Cryoablation of Uterine Fibroids
Acronym
UFREEZE-01
Official Title
Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Withdrawn
Study Start Date
December 2012 (Actual)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IceCure Medical Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Symptomatic Uterine Fibroids
Keywords
cryoablation, uterine fibroid, uterine myoma, who completed her family planning, but wishes to preserve her uterus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
symptomatic UF
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
IceSense3 system
Intervention Description
The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.
Primary Outcome Measure Information:
Title
Improvement in patient's fibroid-related quality of life
Description
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.
Time Frame
12 months
Title
Incidence, subsequent interventions and procedure-related adverse events
Description
To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Reduction in fibroid volume
Description
Reduction in fibroid volume as measured by US/MRI imaging at 6 and 12 months follow-up post treatment comparing to baseline.
Time Frame
12 months
Title
Improvement in menstrual bleeding
Description
Improvement in menstrual bleeding compared to baseline as measured in chemical analysis (Alkaline haematin technique) at 6 and 12 months post treatment.
Time Frame
12 months
Title
Improvement in patient's fibroid-related quality of life
Description
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.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Patient's and physician's overall treatment evaluation
Description
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.
Time Frame
12 months
Title
Patient blood loss
Description
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.
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Moty Pansky, Prof.
Organizational Affiliation
Assaf Harofe Hospital, Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofe
City
Zrifin
ZIP/Postal Code
70300
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Laparoscopic Cryoablation of Uterine Fibroids
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