FibroadenomaICE-CRYSTALNCT00910312
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
A study testing Ice-Sense in people with Fibroadenoma, run by IceCure Medical Ltd. at 4 sites in 3 countries.
Trial summary
The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fibroadenoma
- What is being tested?
- Ice-Sense
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 4 sitesin 3 countries
- Study dates
- Apr 2009to Jan 2013
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is above 18 years old.
- Patient has breast fibroadenoma, proven by biopsy (Core Biopsy).
- Patient's fibroadenoma can be visualized with ultrasound.
- Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension.
- Patient is able to visit the clinic as needed during the 12-month follow-up period following the cryoablation procedure.
- The patient has been informed of the study and agrees to its provisions, and has signed an IRB/EC approved written informed consent, including data privacy authorization.
Who cannot join
- Patients with history of breast cancer.
- Women with known pregnancy.
- Patients with superficial fibroadenoma very close to the skin.
- Patient has undergone major surgery within the previous 12 weeks.
- Patients with any terminal illness, or with a life expectancy <2 year.
- Patients carrying contagious diseases such as Tuberculosis Hepatitis or AIDS.
- Patient participating in other trials using drugs or devices.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Germany2 sites
Department of Obstetrics and Gynecology, University Hospital of Heidelberg
Heidelberg
Department of Obstetrics and Gynecology, University Hospital of Tuebingen
Tübingen
Czechia1 site
Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague
Prague, 128 00
About this study
Official title: Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
The purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma.
- Conditions
- Fibroadenoma
- Being tested
- Ice-Sense
- Medical subject headings
- Fibroadenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ice-SenseDevice
Ice-Sense Cryoprobe
| Study group | Role | What they receive |
|---|---|---|
| Breast Fibroadenoma | Experimental | Not described Receives: Device: Ice-Sense |
What is being measured
The primary outcome is the main question the study is designed to answer.
engulfment of the tumor by the ice-ball as seen under ultrasound imaging
Measured: during the procedure
Secondary outcomes (1)
any device related adverse events or complications that may occur
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2009 (estimated)
- Study startApr 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibroadenomaStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- IceCure Medical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rafi Klein, Dr., Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00910312
- Sponsor's protocol ID
- AM-03
- Other IDs
- version 5.0
- Acronym
- ICE-CRYSTAL
- Status last verified
- Apr 2016
- First submitted
- 28 May 2009
- Last updated
- 17 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
- ClinicalTrials.gov ID
- NCT00910312
- Acronym / sponsor ID
- ICE-CRYSTAL / AM-03
- Conditions
- Fibroadenoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- IceCure Medical Ltd.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 29 May 2009 (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 purpose of this study is to determine whether the Ice-Sense, a novel cryotherapy system (a system that freezes tissues), is safe and effective in the treatment of benign breast tumors such as fibroadenoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Fibroadenoma | Experimental | Device: Ice-Sense |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient is above 18 years old.
- Patient has breast fibroadenoma, proven by biopsy (Core Biopsy).
- Patient's fibroadenoma can be visualized with ultrasound.
- Patient's fibroadenoma size is between 0.5cm and 3cm at its largest dimension.
- Patient is able to visit the clinic as needed during the 12-month follow-up period following the cryoablation procedure.
Key exclusion criteria (7 listed)
- Patients with history of breast cancer.
- Women with known pregnancy.
- Patients with superficial fibroadenoma very close to the skin.
- Patient has undergone major surgery within the previous 12 weeks.
- Patients with any terminal illness, or with a life expectancy <2 year.
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 |
|---|---|---|
| Ice-SenseIce-Sense Cryoprobe | Device | Breast Fibroadenoma |
Primary outcome
engulfment of the tumor by the ice-ball as seen under ultrasound imaging
Time frame: during the procedure
1 secondary outcome
any device related adverse events or complications that may occur
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2022.
Related trials for Fibroadenoma
Not yet recruiting
Management of Breast Fibroadenoma: Comparing Observation, Microwave Ablation, and Surgical Excision
Fibroadenoma, Breast Fibroadenoma
Not yet recruiting
SafeLM Versus LMA Classic for Airway Management During Fibroadenoma Excision
Airway Management
Not yet recruiting
Ultrasound-Guided Microwave Ablation for Breast Fibroadenoma: Safety and Cosmetic Outcomes
Breast Fibroadenoma
RecruitingObservational study
ATUSA Ultrasound Diagnostic Imaging for Breast Lesions Evaluation (AUDIBLE) - iSono Health
Breast Cancer, Benign Breast Condition
RecruitingPhase 1
Medical Imaging and Focused Ultrasound Treatment for Breast Tumors Using Harmonic Motion Imaging (HMI)
Fibroadenoma, Breast Cancer Stage I
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.
Rafi Klein, Dr. principal investigator
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ice-Sense in people with Fibroadenoma, run by IceCure Medical Ltd. at 4 sites in 3 countries.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 17 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Germany, Czechia, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
engulfment of the tumor by the ice-ball as seen under ultrasound imaging (time frame: during the procedure). 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 17 Aug 2022.