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New treatment option for Breast Cancer
Official title Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
ClinicalTrials.gov ID: NCT07206121
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 50 and older, women only
You may be able to join if
- Biologic female
- 50 years of age and older
- Confirmed diagnosis of breast cancer:
- Infiltrating ductal carcinoma
- ER/PR+Her2neu-
You likely can't join 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
See the full eligibility criteria
- Biologic female
- 50 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Galveston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 50 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Galveston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.