Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

Prophylactic Mastectomy Clinical Trial

Official title:

Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02614885
• Other study ID #: 2015-01
• Status: Completed
• Phase: N/A
• First received: November 20, 2015
• Last updated: November 9, 2017
• Start date: July 20, 2016
• Est. completion date: August 17, 2017

Study information

• Verified date: November 2017
• Source: Innoblative Designs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 17, 2017
• Est. primary completion date: June 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Prophylactic Mastectomy

Intervention

Device:
• RFA
Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Innoblative Designs, Inc.	University of Arkansas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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