Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

NCT02614885 | Completed DMC

• 1 other identifier: 2015-01
• Study Type: observational
• Target: 11
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Prophylactic Mastectomy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Prophylactic Mastectomy

Females undergoing prophylactic mastectomy with RFA performed on the excised tissue.

Device: RFA

Interventions

RFA DEVICE

Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.

Prophylactic Mastectomy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presenting for prophylactic mastectomy.

You may qualify if:

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

You may not qualify if:

• The patient is receiving a skin sparing mastectomy(s)
• The patient has had previous exposure to chemotherapy or radiation therapy
• The patient has implants in the breast(s) to be included in the study
• The patient is currently pregnant or lactating
• 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)
• 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)
• 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

Sponsors & Collaborators

• Innoblative Designs, Inc.: lead
• University of Arkansas: collaborator

Study Officials

• Daniela A Ochoa, MD

  UAMS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2015
• First Posted: November 25, 2015
• Study Start: July 20, 2016
• Primary Completion: June 15, 2017
• Study Completion: August 17, 2017
• Last Updated: November 14, 2017

Record last verified: 2017-11