NCT02614885

Feasibility Study of Cavitary Radiofrequency Ablation in Excised Mastectomy Breast Tissue

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 11 (actual)
• Sponsor: Innoblative Designs, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Prophylactic Mastectomy

Interventions

Type	Name	Description
DEVICE	RFA	Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.

Timeline

• Start date: 2016-07-20
• Primary completion: 2017-06-15
• Completion: 2017-08-17
• First posted: 2015-11-25
• Last updated: 2017-11-14