Clinical Information

The FDA cleared the Visica® Treatment system in 2001 and the Visica® 2 in 2007. Thousands of patients have been successfully treated for benign breast tumors without surgery. Visica has been used on cancerous or malignant tissue and benign tumors in the breast. The cryoablation device has been used in clinical trials, cryo-assisted lumpectomies registry and dozens of cryo-only procedures. Currently, Sanarus is working diligently to make minimally invasive cryoablation the standard of care for breast cancer and is sponsoring clinical studies to make that a reality.

In 2016, the Annals of Surgical Oncology published the results of the National Cancer Institute (NCI) Sponsored study ACOSOG (Alliance) Z1072 Phase II, single arm non-randomized study in the treatment of invasive breast disease. The Visica Treatment System was the exclusive device used in this landmark study.

The results of the ACOSOG Z1072 are as follow:

  • 100% ablation in all tumors < 1.0 cm in size, defined as no remaining invasive breast cancer (IBC) or ductal carcinoma in situ (DCIS) on pathological examination of the tumor
  • Cryoablation was effective in 92% of all targeted tumors
  • No cases were categorized as ineffective ablation within the cryoablation zone (all cancer cells within the treatment zone were killed)

To review the Z1072 abstract, please click here

Sanarus Technologies is sponsoring a multi-center clinical study (FROST), A Study of Cryoablation in the Management of Early Stage Breast Cancer, for patients who prefer an alternative to surgery. To learn more about the FROST clinical study, please click here.

Should I participate in a clinical study?

Taking part in a clinical study is one way of making a contribution to the advancement of medical technology and to receive the newest forms of treatment. Your decision to participate should be made only with a full understanding of the risks involved. Consult your physician before deciding.

Where to learn more

For more information about clinical trials, visit:

Understanding Clinical Trials [https://clinicaltrials.gov/ct2/about-studies/learn]

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