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SIRA-1000 Device for Breast Cancer Surgery Margins

This study is testing a new device called SIRA-1000, an electrosurgical device that uses radiofrequency ablation (RFA) to treat the edges (margins) of the area where a breast tumor was removed during breast-conserving surgery. RFA uses heat from radio waves to destroy any remaining cancer cells in these margins. The study aims to see how safe the SIRA-1000 device is and how well it works to create a 1 cm deep area of treated tissue around the tumor site. You may be able to join if you are a woman aged 50 or older with a specific type of breast cancer (infiltrating ductal carcinoma, ER/PR+Her2neu-, Grade I, II, or III) that is 3 cm or smaller and located at least 2 cm from the skin. The study plans to enroll 10 participants.

Study design
This is an interventional study, but the phase is not specified. It plans to enroll 10 participants.
What's involved
During your surgery, after the tumor is removed, the SIRA-1000 device will be used in the breast cavity. Tissue samples will be taken for review, and your recovery will be like any other surgery.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 5 years after the procedure, with a healing process assessment at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07206121

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

Recruiting
NAAges 50+Interventional
Innoblative Designs, Inc.
~10 participants
Updated 2026-02-11 on ClinicalTrials.gov
What's tested:Radiofrequency ablation aloneRadiofrequency ablation Electrosurgical Device

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events.
Measured over The study will span a total of approximately 12 months with a follow-up for 5 years.
+1 more outcome measured

Conditions

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

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Where it's being run

1 sites across 1 states
Texas1

Study leadership

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

Who to contact

Clinical Trials Manager
[email protected]
833-920-4660
Email the study team

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What this trial measures

  • 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 Questionnaire6 months

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