MedTrace Logo

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

NCT07206121 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-02-11

No results posted yet for this study

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

Interventions

DEVICE

Radiofrequency ablation alone

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.

DEVICE

Radiofrequency ablation Electrosurgical Device

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

Sponsors & Collaborators

  • Innoblative Designs, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2027-02-06
Completion
2032-02-06
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07206121 on ClinicalTrials.gov