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

Part of paid clinical trials in Galveston, Texas.

Sponsor
Innoblative Designs, Inc.
Study ID
NCT07206121
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
FEMALE
Age
50 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Radiofrequency ablation Electrosurgical Device — DEVICE
    SIRA-1000 an radiofrequency ablation device, is designed to fit the post-lumpectomy cavity to provide uniform ablation.

Study Details

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.

Key Dates

Start date
Feb 10, 2026
Status verified
Sep 2025
Primary completion
Feb 6, 2027
Completion
Feb 6, 2032

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: Feasibility and safety study for women undergoing BCS.
    RFA electrosurgical device as an adjunct to BCS.

Primary Outcome Measure

To assess the safety of SIRA-1000 by summarizing the occurrence of Adverse Events. [ Time Frame: The study will span a total of approximately 12 months with a follow-up for 5 years. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Texas Medical Branch at Galveston, TXGalvestonTexas60612
Sr. Clinical Research Coordinator
[email protected]
409-772-1983
Senior Research Coordinator
[email protected]
409-266-6388
Raj G. Vaghjiani, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Galveston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Texas Medical Branch at Galveston, TX· Galveston, TX

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