SIRA-1000 radiofrequency ablation of lumpectomy margins

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

During lumpectomy the surgeon places the SIRA-1000 device into the surgical cavity and applies radiofrequency energy to ablate tissue at the specimen margins, with a stitch used to stabilize the device and maintain contact. The removed tumor and tissue from the ablated edges are sent for pathology to determine whether the targeted ablation achieved thermal destruction of residual cancer cells. The trial enrolls biologic females aged 50 and older with unicentric, unilateral ER/PR+ Her2- invasive ductal carcinoma ≤3 cm and tumors located at least 2 cm from the skin, while excluding patients with implants, implanted electronic devices, neoadjuvant chemotherapy, multicentric disease, or other listed conditions. The procedure is performed at a single center (University of Texas Medical Branch at Galveston) and the primary focus is on safety and clinical accuracy of margin ablation using the SIRA-1000 as an adjunct to standard surgery.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Biologic female
2. 50 years of age and older
3. Confirmed diagnosis of breast cancer:

   1. Infiltrating ductal carcinoma
   2. ER/PR+Her2neu-
   3. Grade I, II, or III
4. Unicentric, unilateral tumor size ≤ 3cm
5. Tumor location ≥ 2 cm from skin and other structures
6. Zubrod Performance Status of 0, 1, or 2
7. No palpable lymphadenopathy
8. Able and willing to provide written informed consent

Exclusion Criteria:

1. Pregnant or breastfeeding
2. Neoadjuvant chemotherapy
3. Cardiac arrhythmia
4. Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device
5. Current or history of breast implants
6. Multi-centric or bilateral breast cancer
7. Diffuse microcalcifications
8. Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study
9. Has a condition or is in a situation which in the Investigator's opinion may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.

Where it's running

• University of Texas Medical Branch at Galveston, TX
  Galveston, Texas, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Manager
• Email: kathy@innoblative.com
• Phone: 833-920-4660

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.