Radiofrequency Ablation Device for Breast Cancer

Overseen By Clinical Trials Manager

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Innoblative Designs, Inc.

Disqualifiers: Pregnant, Breastfeeding, Cardiac arrhythmia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the SIRA-1000, a radiofrequency ablation (RFA) electrosurgical device, to help treat breast cancer. After a lumpectomy, the device uses radio waves to heat and destroy any remaining cancer cells around the tumor's original location. The trial targets women with a specific type of breast cancer, with tumors no larger than 3 cm, who have already undergone surgery to remove the lump. Participants should not have breast implants or pacemakers and must have a confirmed diagnosis of certain breast cancer types, such as infiltrating ductal carcinoma. The goal is to determine if this device is safe and effective in clearing cancer cells near the tumor site. As an unphased trial, this study offers participants the opportunity to contribute to pioneering research in breast cancer treatment.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.

What prior data suggests that this device is safe for breast cancer patients?

Research shows that the SIRA-1000, a device using radio waves, is undergoing tests for safety and effectiveness in breast cancer surgery. This device generates heat to destroy any remaining cancer cells after a lumpectomy, which is surgery to remove a breast lump.

Although detailed safety information from these studies is not yet available, the device has received an Investigational Device Exemption (IDE) from the FDA. This indicates it has shown enough promise in early tests to be tried in human studies. However, like any new treatment, risks and side effects may still be under investigation. Always discuss any concerns with a doctor before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SIRA-1000 and the SIRA® RFA Electrosurgical Device because they offer a unique approach to treating breast cancer. Unlike standard treatments like surgery, chemotherapy, or radiation, which can be extensive and have significant side effects, these devices use radiofrequency ablation (RFA) as an adjunct to breast-conserving surgery (BCS). This technique precisely targets and destroys cancer cells with heat, potentially minimizing damage to surrounding healthy tissue. This could lead to quicker recovery times and fewer complications, making it a promising option for patients.

What evidence suggests that this device is effective for breast cancer?

This trial examines the feasibility and safety of the SIRA-1000 device as an adjunct to breast-conserving surgery (BCS). Studies have shown that the SIRA-1000 device can reduce the need for additional surgeries after BCS. The device uses heat from radio waves to destroy any leftover cancer cells around the tumor removal site. Research indicates that this device may lower the chances of cancer returning by effectively treating the edges of the removed tumor. By reducing the number of positive margins, the device aims to decrease the need for repeat surgeries. Early findings suggest that this method can be a safe and accurate option for treating breast cancer. ^{1 3 4 6 7}

Who Is on the Research Team?

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

Principal Investigator

Are You a Good Fit for This Trial?

This trial is for patients undergoing breast conserving surgery for breast cancer. It's testing the SIRA-1000 device to ablate tissue around where a tumor was removed. Participants should be eligible for this type of surgery and have no conditions that exclude them from safely using RFA.

Inclusion Criteria

I am a biological female.

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

I am 50 years old or older.

Exclusion Criteria

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

Pregnant or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and RF Ablation

During surgery, the SIRA-1000 device is used for RF ablation to treat the margins of the lumpectomy site.

1 day

1 visit (in-person)

Immediate Post-Surgery Follow-up

Participants are monitored for immediate post-surgical recovery and adverse events.

1-2 weeks

Long-term Follow-up

Participants are monitored for safety and effectiveness, including adverse events and healing process, using the BREAST-Q Questionnaire.

5 years

What Are the Treatments Tested in This Trial?

Interventions

• SIRA-1000, SIRA® RFA Electrosurgical Device

Trial Overview The study tests the SIRA-1000, an electrosurgical device used in radiofrequency ablation (RFA) post-lumpectomy. The goal is to see if it can accurately and safely destroy any remaining cancer cells at the margins around the lump site.

How Is the Trial Designed?

Group I: Feasibility and safety study for women undergoing BCS. Experimental Treatment 2 Interventions

RFA electrosurgical device as an adjunct to BCS.

Who Is Running the Clinical Trial?

Innoblative Designs, Inc.

Lead Sponsor

Trials

2

Recruited

10+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07206121?term=stem+cells

NCT07206121 | Feasibility Study for the SIRA-1000, ... 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 ...

2. prnewswire.com prnewswire.com/news-releases/innoblative-receives-us-ide-approval-for-its-novel-electrosurgical-device-for-breast-cancer-treatment-302425040.html

Innoblative Receives U.S. IDE Approval for its Novel ... The SIRA device aims to provide a reduction in positive margin rates, reduce BCS reoperations, and offer a one-time non-ionizing therapeutic ...

3. cancernetwork.com cancernetwork.com/view/fda-grants-ide-to-electrosurgical-device-for-breast-conservation-surgery

FDA Grants IDE to Electrosurgical Device For Breast- ... The developers noted that the goals of the SIRA device are to reduce positive margin rates, reduce breast-conservation surgery reoperations, and ...

4. withpower.com withpower.com/trial/phase-breast-conserving-surgery-10-2025-e0833

Radiofrequency Ablation Device for Breast Cancer This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins ...

5. pharmabiz.com pharmabiz.com/NewsDetails.aspx?aid=177319&sid=2

US FDA grants IDE approval to Innoblative's SIRA RFA ... RF ablation has been shown in multiple long-term clinical studies to reduce reoperations and may reduce local recurrence in breast cancer ...

6. innoblative.com innoblative.com/innoblative-receives-us-ide-approval/

Innoblative Receives U.S. IDE Approval for its Novel ... The study will evaluate the safety and effectiveness of the company's SIRA® RFA Electrosurgical Device in patients undergoing breast- ...

7. trial.medpath.com trial.medpath.com/clinical-trial/d8455452254de096/nct07206121-sira-1000-sira-rfa-breast-conserving-surgery

Feasibility Study for the SIRA-1000, SIRA® RFA ... - MedPath This study aims to assess the safety and clinical accuracy of the SIRA-1000, SIRA® RFA Electrosurgical Device in ablating margins post-lumpectomy...