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Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
Sponsor: Innoblative Designs, Inc.
Summary
This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy in patients undergoing breast conserving surgery for breast cancer. Radiofrequency ablation, or RFA, uses radio waves to create heat, that in turn, causes deliberate controlled damage to the tissue surrounding where the tumor was located. You may hear your doctor refer to this as the 'margins'. Your doctor is using this treatment to help destroy remaining cancer cells in the margins around the site of the lump.
Official title: A Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
Key Details
Gender
FEMALE
Age Range
50 Years - Any
Study Type
INTERVENTIONAL
Enrollment
10
Start Date
2026-02-10
Completion Date
2032-02-06
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Radiofrequency ablation alone
Demonstrate the accuracy of the device to produce approximately 1 cm depth of ablation around the tumor bed, as evaluated by post-ablation tissue samples at least 1cm deep.
Radiofrequency ablation Electrosurgical Device
SIRA-1000 an radiofrequency ablation device, is designed to fit the post-lumpectomy cavity to provide uniform ablation.
Locations (1)
University of Texas Medical Branch at Galveston, TX
Galveston, Texas, United States