Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy (CRYOSE01)
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|ClinicalTrials.gov Identifier: NCT02576106|
Recruitment Status : Completed
First Posted : October 15, 2015
Last Update Posted : October 22, 2020
The primary objective of this monocentric and feasibility study is to review the efficacy of cryotherapy in the treatment of unifocal mammary carcinomas in post-menopausal patients, with lumpectomy indication.
The efficacy is defined by the rate of success of cryotherapy procedures. For each one of those evaluated process, an success will be defined on the tumor sample of lumpectomy by the absence of viable tumour cells.
On the basis of our expertise, it seems interesting to propose this experimental procedure to patients as described above.
|Condition or disease||Intervention/treatment||Phase|
|Carcinoma, Ductal, Breast Menopausal||Device: Cryoablation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Percutaneous Treatment by Cryoablation of Unifocal Invasive Breast Carcinoma in Menopausal Women With Indication of Lumpectomy|
|Actual Study Start Date :||February 2016|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
Cryoablation of the tumor followed by a lumpectomy as practiced in standard care
Other Name: Cryotherapy
- The rate of success of cryoablation procedure [ Time Frame: 45 days after cryoablation ]percentage of viable cells in the piece of lumpectomy
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576106
|Centre Léon Bérard|
|Lyon, France, 69008|
|Principal Investigator:||Frank Pilleul, MD-PhD||Centre Leon Berard|