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

NCT07206121 | Recruiting FDA Device

• 1 other identifier: 28001-CSP
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer; Breast-conserving Surgery; ER/PR+Her2neu; Grade I, II, III; Breast Cancer - Infiltrating Ductal Carcinoma

Keywords

Breast conserving surgery for breast cancer.

Outcome Measures

Primary Outcomes (2)

• To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events.

  Assess the occurrence adverse events and to evaluate the impact of RFA on healing process.

  The study will span a total of approximately 12 months with a follow-up for 5 years.

• Healing Process assessed by BREAST-Q Questionnaire

  Assess healing process using cosmesis and quality of life patient reported outcomes.

  6 months

Study Arms (1)

Feasibility and safety study for women undergoing BCS.

EXPERIMENTAL

RFA electrosurgical device as an adjunct to BCS.

Device: Radiofrequency ablation alone; Device: Radiofrequency ablation Electrosurgical Device

Interventions

Radiofrequency ablation alone DEVICE

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.

Feasibility and safety study for women undergoing BCS.

Radiofrequency ablation Electrosurgical Device DEVICE

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

Feasibility and safety study for women undergoing BCS.

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Biologic female
• years of age and older
• Confirmed diagnosis of breast cancer:
• Infiltrating ductal carcinoma
• ER/PR+Her2neu-
• Grade I, II, or III
• Unicentric, unilateral tumor size ≤ 3cm
• Tumor location ≥ 2 cm from skin and other structures
• Zubrod Performance Status of 0, 1, or 2
• No palpable lymphadenopathy
• Able and willing to provide written informed consent

You may not qualify if:

• Pregnant or breastfeeding
• Neoadjuvant chemotherapy
• Cardiac arrhythmia
• Patients with active implantable medical devices, such as implanted cardiac pacemakers or defibrillators, or any other electronic device
• Current or history of breast implants
• Multi-centric or bilateral breast cancer
• Diffuse microcalcifications
• Participating in another ongoing clinical study in which concomitant diagnostic or therapeutic intervention that would reasonably be expected to alter the outcomes under study
• 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.

Sponsors & Collaborators

• Innoblative Designs, Inc.: lead

Study Sites (1)

University of Texas Medical Branch at Galveston, TX

Galveston, Texas, 60612, United States

RECRUITING

Related Publications (1)

• Klimberg VS, Ochoa D, Henry-Tillman R, Hardee M, Boneti C, Adkins LL, McCarthy M, Tummel E, Lee J, Malak S, Makhoul I, Korourian S. Long-term results of phase II ablation after breast lumpectomy added to extend intraoperative margins (ABLATE l) trial. J Am Coll Surg. 2014 Apr;218(4):741-9. doi: 10.1016/j.jamcollsurg.2013.12.032. Epub 2014 Jan 11.

  PMID: 24655863 BACKGROUND

Related Links

• Innoblative Designs, Inc. website

MeSH Terms

Conditions

Breast Neoplasms; Lymphoma, Follicular

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• V. Suzanne Klimberg, MD, PhD, MSCHT, MAMSE, FACS

  STUDY CHAIR

Central Study Contacts

Clinical Trials Manager

CONTACT

833-920-4660; kathy@innoblative.com

VP Quality Assurance & Regulatory Affairs

CONTACT

833-920-4660; kcrowley@innoblative.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Safety study.

Study Record Dates

• First Submitted: September 18, 2025
• First Posted: October 3, 2025
• Study Start: February 10, 2026
• Primary Completion (Estimated): February 6, 2027
• Study Completion (Estimated): February 6, 2032
• Last Updated: February 11, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)