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NCT07206121
Feasibility Study for the SIRA-1000, SIRA® RFA Electrosurgical Device as an Adjunct to Breast Conserving Surgery
NA trial testing Radiofrequency ablation alone in Breast Cancer in 10 participants. Currently enrolling.
6 February 2027
Quick facts
| Lead sponsor | Innoblative Designs, Inc. |
|---|---|
| Phase | NA |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 10 |
| Start date | 10 February 2026 |
| Primary completion | 6 February 2027 |
| Estimated completion | 6 February 2032 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Radiofrequency ablation alone — full drug profile →
- Radiofrequency ablation Electrosurgical Device
Conditions studied
- Breast Cancer — all drugs for Breast Cancer →
- Breast-conserving Surgery — all drugs for Breast-conserving Surgery →
- Breast Cancer - Infiltrating Ductal Carcinoma — all drugs for Breast Cancer - Infiltrating Ductal Carcinoma →
- ER/PR+Her2neu — all drugs for ER/PR+Her2neu →
Sponsor
Innoblative Designs, Inc.
Who can join
50 and older, female only, with Breast Cancer or Breast-conserving Surgery. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT07206121
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Innoblative Designs, Inc. trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07206121 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Innoblative Designs, Inc.
- Last refreshed: 11 February 2026
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07206121.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing