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

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

Study 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.

Eligibility

Primary outcome measure(s)

• To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events. — The study will span a total of approximately 12 months with a follow-up for 5 years.
  Assess the occurrence adverse events and to evaluate the impact of RFA on healing process.
• Healing Process assessed by BREAST-Q Questionnaire — 6 months
  Assess healing process using cosmesis and quality of life patient reported outcomes.

Trial sites (1)

Other trials for the same condition