Clinical trial · Interventional
ICE-SENSE™ Cryotherapy for Breast Fibroadenoma Trial
Evaluation of Safety and Feasibility of the ICE-SENSE™, a Cryotherapy Device for Office-based Ultrasound-guided Treatment of Breast Fibroadenoma
NCT00910312CI-TRIAL-00060371ICE-CRYSTALcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Fibroadenoma | Breast Fibroadenoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ice-Sense | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Fibroadenoma
- interventionNames
- Device: Ice-Sense
Primary outcomes (1)
- measure
- engulfment of the tumor by the ice-ball as seen under ultrasound imaging
- timeFrame
- during the procedure
Secondary outcomes (1)
- measure
- any device related adverse events or complications that may occur
- timeFrame
- one year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available
No reference posted for this study.