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

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.

Trial Details

NCT ID

NCT07206121

Phase

NA

Sponsor

Innoblative Designs, Inc.

Status

RECRUITING

Cancer Type

Breast Cancer

Interventions

• Radiofrequency ablation alone
• Radiofrequency ablation Electrosurgical Device

Locations (sample)

• Galveston, Texas, United States|29.30135,-94.7977

Key Eligibility Criteria

• Biologic female
• 50 years of age and older
• Confirmed diagnosis of breast cancer:
• Infiltrating ductal carcinoma

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

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