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Procedure

Low Risk - Age 70+ for Breast Cancer (FROST Trial)

N/A

Waitlist Available

Led By Dennis R. Holmes, MD, FACS

Research Sponsored by Sanarus Technologies, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

FROST Trial Summary

This trial is testing whether cryoablation, which involves freezing and destroying abnormal tissue, can be an effective treatment for early stage breast cancer in select patients who would otherwise undergo surgery.

Eligible Conditions

Breast Cancer

FROST Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Tumor ablation occurence

Secondary outcome measures

Adverse event assessment

Local tumor recurrence

Satisfactory breast cosmesis results

FROST Trial Design

2Treatment groups

Experimental Treatment

Group I: Moderate Risk - Age 50-69Experimental Treatment1 Intervention

Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies

Group II: Low Risk - Age 70+Experimental Treatment1 Intervention

Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Sanarus Technologies, Inc.Lead Sponsor

Dennis R. Holmes, MD, FACSPrincipal Investigator90210 Surgery Medical Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any open slots in this experiment for participants?

"The data found on clinicaltrials.gov suggests that this medical trial is presently recruiting individuals for the study, which was first listed in November 2013 and last updated in April 2018."

Answered by AI

How many individuals have been accepted for participation in this experiment?

"Sanarus Technologies, Inc., will be conducting the trial at Epic Care in Emeryville, California and Naples Community Hospital in Naples, Florida. 200 eligible individuals must participate to ensure successful execution of this clinical study."

Answered by AI

How many venues are presently conducting this experiment?

"The trial is actively running at 12 sites throughout the United States, including Emeryville, Naples and Lubbock. It's recommended to select your nearest site in order to decrease travel needs if you choose to partake."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

2013. "Cryoablation of Small Breast Tumors in Early Stage Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01992250.