Recruiting

Cryoablation

Sponsor:

Sanarus Technologies, Inc.

Code:

NCT01992250

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Visica 2 Treatment System

Study Details

Brief summary:

This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.

Conditions

Breast Cancer

Study ID

NCT01992250

Start date

Nov, 2013

Status verified date

Apr, 2018

Completion date

Jun, 2023

Anticipated

Primary completion date

Dec, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 50+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Age ≥ 50
2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
3. Maximum tumor size ≤1.5 cm in its greatest diameter
4. Ultrasound visible lesion(s)
5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25% intraductal component in the aggregate.
6. Unilateral or bilateral disease meeting study criteria
7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis
8. Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease

Exclusion Criteria:

1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer
2. Ductal carcinoma in-situ with microinvasions (T1mic)
3. Multifocal or multicentric invasive breast carcinoma
4. Prior or planned neoadjuvant systemic therapy for breast cancer
5. Tumor with ≥25% IDC components

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: Low Risk - Age 70+

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

other: Moderate Risk - Age 50-69

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

Interventions

Visica 2 Treatment System

Cryoablation

Primary outcome measure

  • Tumor ablation occurence [ Time Frame: Within 6 months ]

Central Contacts and Locations

Central contacts

Locations

Arizona Breastnet

Recruiting

Scottsdale, Arizona, United States, 85260

Contacts

Principal Investigator:

Belinda Barcley-White, MD

90210 Surgery Medical Center

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Principal Investigator:

Dennis R. Holmes, MD, FACS

City of Hope

Recruiting

Duarte, California, United States, 91010

Contacts

Blanca Mendez, BSHS CRCII

626-218-0433blmendez@coh.org

Luci Tumyan, MD

626-218-0433

Epic Care

Recruiting

Emeryville, California, United States, 94608

Contacts

Diagnostic Center for Women, LLC

Recruiting

Miami, Florida, United States, 33173

Contacts

Michael J Plaza, M.D.

305-740-5100

Cristina Upegui

305-740-5100

Naples Community Hospital

Recruiting

Naples, Florida, United States, 34109

Contacts

Principal Investigator:

Sharla Patterson, MD

Ascension Crittenton Hospital

Recruiting

Rochester, Michigan, United States, 48307

Contacts

Principal Investigator:

Peter J. Littrup, M.D.

Lankenau Medical Center

Recruiting

Wynnewood, Pennsylvania, United States, 19096

Contacts

Sharon Steinberg, BS, RN, OCN

484-476-2395SteinbergS@MLHS.ORG

Elene Turzo, MSN, CRNP

484-476-2649

Principal Investigator:

Ned Z Carp, M.D.

Rhode Island Hospital

Recruiting

Providence, Rhode Island, United States, 02903

Contacts

Principal Investigator:

Robert Ward, M.D>

Knoxville Comprehensive Breast Center

Recruiting

Knoxville, Tennessee, United States, 37909

Contacts

Principal Investigator:

Kamilia Kozlowski, MD

Texas Tech University Health Sciences Center

Recruiting

Lubbock, Texas, United States, 79416

Contacts

Principal Investigator:

Rakhshanda Rahman, MD

Ogden Regional Hospital

Recruiting

Ogden, Utah, United States, 84405

Contacts

Principal Investigator:

Jose Tamayo, MD

More Information

Sponsor

Sanarus Technologies, Inc.

Last update posted

Apr 20, 2018

Last verified

Apr, 2018

Keywords

  • Cryoablation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sanarus Technologies, Inc. on 2018-04-20.