Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

This is a single-arm, prospective study of a radiofrequency ablation device on the excised breast tissue of ten (10) prophylactic mastectomy patients. The ablation lesion created by the device will be analyzed histologically.

Study Overview

• Status: Completed
• Conditions: Prophylactic Mastectomy
• Intervention / Treatment: Device: RFA

Detailed Description

This study is a single-center, prospective, open label study of a radiofrequency ablation device. 10 patients who are scheduled to undergo prophylactic mastectomy will be recruited by the clinical investigators at the investigational site in accordance with the inclusion and exclusion criteria. Once the breast tissue is removed, the radiofrequency ablation device will be used on the ex vivo tissue to ablate a lesion around a cavity created in the tissue. The ablation lesion will be characterized. The study period per subject is the time it takes to assess the ablation lesion histologically.

• Study Type: Observational
• Enrollment (Actual): 11

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for prophylactic mastectomy.

Description

Inclusion Criteria:

1. Female
2. At least 18 years of age
3. Scheduled to receive a standard of care prophylactic mastectomy (or prophylactic bi-lateral mastectomy)
4. The patients' breast(s) to be included in the study are undiseased
5. The patient has adequate breast volume for ex vivo ablation procedure

Exclusion Criteria:

1. The patient is receiving a skin sparing mastectomy(s)
2. The patient has had previous exposure to chemotherapy or radiation therapy
3. The patient has implants in the breast(s) to be included in the study
4. The patient is currently pregnant or lactating
5. The patient has tissue markers implanted in the breast to be included in the study (unless these can be removed when creating a cavity in the ex vivo breast tissue)
6. The patient has had previous surgery on the breast(s) to be included in the study (unless study investigator determines that this will not affect the validity of data in this study)
7. The patient in participating in any other clinical study of a device or drug that may impact the participant safety of the validity of data acquired in this study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prophylactic Mastectomy; Females undergoing prophylactic mastectomy with RFA performed on the excised tissue.	Device: RFA; Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histologic measurement of cavitary ablation lesions created by the Innoblative radiofrequency ablation device in ex vivo breast tissue to correlate ablation size with ablation parameters.	Histologic analysis of ablation depth around the cavity.	Two weeks after surgery

Collaborators and Investigators

• Sponsor: Innoblative Designs, Inc.
• Collaborators: University of Arkansas
• Investigators: Principal Investigator: Daniela A Ochoa, MD, UAMS

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 20, 2016
• Primary Completion (ACTUAL): June 15, 2017
• Study Completion (ACTUAL): August 17, 2017

Study Registration Dates

• First Submitted: November 20, 2015
• First Submitted That Met QC Criteria: November 23, 2015
• First Posted (ESTIMATE): November 25, 2015

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 9, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2015-01