NCT07206121View on ClinicalTrials.gov

Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery

NANot yet recruitingINTERVENTIONAL
Enrollment

10

Participants

Timeline

Start Date

November 1, 2025

Primary Completion Date

November 1, 2026

Study Completion Date

November 1, 2031

Conditions
Breast CancerBreast-conserving SurgeryBreast Cancer - Infiltrating Ductal CarcinomaER/PR+Her2neuGrade I, II, III
Interventions
DEVICE

Radiofrequency ablation alone

Demonstrate the accuracy of the device to produce 1 cm depth of ablation around the tumor bed, as evaluated by post-ablation deep shave margins.

DEVICE

Radiofrequency ablation Electrosurgical Device

SIRA-1000 an radiofrequency ablation device, is designed to fit the post-lumpectomy cavity to provide uniform ablation.

Trial Locations (1)

60612

University of Texas Medical Branch at Galveston, TX, Galveston

Sponsors
All Listed Sponsors
lead

Innoblative Designs, Inc.

INDUSTRY