Symptomatic Uterine FibroidsUFREEZE-01NCT01735812
Laparoscopic Cryoablation of Uterine Fibroids
A study testing IceSense3 system in people with Symptomatic Uterine Fibroids, run by IceCure Medical Ltd. at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Symptomatic Uterine Fibroids
- What is being tested?
- IceSense3 system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Symptomatic Uterine Fibroids
- Being tested
- IceSense3 system
- Keywords
- cryoablation, uterine fibroid, uterine myoma, who completed her family planning, but wishes to preserve her uterus
- Medical subject headings
- Leiomyoma, Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IceSense3 systemDevice
The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.
| Study group | Role | What they receive |
|---|---|---|
| symptomatic UF | Experimental | Not described Receives: Device: IceSense3 system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 12 months
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Uterine FibroidsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- IceCure Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Moty Pansky, Prof., Principal investigator, Assaf Harofe Hospital, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735812
- Sponsor's protocol ID
- ICUFL-01
- Acronym
- UFREEZE-01
- Status last verified
- Nov 2012
- First submitted
- 26 Nov 2012
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation of Symptomatic Uterine Fibroids Using the IceSense3™ System in a Percutaneous Laparoscopic-assisted Approach
- ClinicalTrials.gov ID
- NCT01735812
- Acronym / sponsor ID
- UFREEZE-01 / ICUFL-01
- Conditions
- Symptomatic Uterine Fibroids
- Keywords
- cryoablation, uterine fibroid, uterine myoma, who completed her family planning, but wishes to preserve her uterus
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IceCure Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Dec 2012 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| symptomatic UF | Experimental | Device: IceSense3 system |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IceSense3 systemThe IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications. | Device | symptomatic UF |
Primary outcome
Improvement in patient's fibroid-related quality of life
Time frame: 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
Time frame: 12 months
To evaluate procedural safety by monitoring incidence, subsequent interventions and procedure-related adverse events within 12 months of treatment
3 secondary outcomes
Reduction in fibroid volume
Time frame: 12 months
Improvement in menstrual bleeding
Time frame: 12 months
Improvement in patient's fibroid-related quality of life
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Moty Pansky, Prof. principal investigator
Assaf Harofe Hospital, Israel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IceSense3 system in people with Symptomatic Uterine Fibroids, run by IceCure Medical Ltd. at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in patient's fibroid-related quality of life (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2022.