Clinical trial · Interventional
Minimal Invasive Breast Cancer Excision Using the Breast Lesion Excision System Under Ultrasound Guidance
NCT02975128CI-TRIAL-00045313BLESterminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Needle production stopped
Summary
Brief summary (as posted)
This study will assess whether it is feasible to remove small breast cancers completely using the Breast Lesion Excision System under Ultrasound guidance.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breastcancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BLES system and conventional lumpectomy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients
- interventionNames
- Device: BLES system and conventional lumpectomy
Primary outcomes (1)
- measure
- Frequency of successful complete tumor excision by the BLES system.
- timeFrame
- Through study completion, an average of two months
- description
- Successful is defined as 'having tumor free margins, and no residual (in situ) cancer in the surgical specimen'.
Secondary outcomes (3)
- measure
- Quality of the margin evaluation of the biopsy specimen and the eventual surgical specimen.
- timeFrame
- Through study completion, an average of two months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Female * 19 years or older * US visible breast cancer with maximum diameter of 15 mm on US * Histologically proven invasive breast cancer * Willing and able to undergo preoperative breast MRI * Able to provide informed consent Exclusion Criteria: * Poor US visibility of the breast cancer * Breast cancer closer than 6 mm to the dermis, nipple or pectoral muscle. * Contra-indications to breast MRI or intravenous contrast administration * Contra-indications for the use of diathermia * Unable to provide informed consent * Patients with breast implants * Patients with implanted electronics * Pregnancy * Neoadjuvant chemotherapy
References
Publications (4)
- BACKGROUNDAllen SD, Nerurkar A, Della Rovere GU. The breast lesion excision system (BLES): a novel technique in the diagnostic and therapeutic management of small indeterminate breast lesions? Eur Radiol. 2011 May;21(5):919-24. doi: 10.1007/s00330-010-2000-7. Epub 2011 Jan 15. PMID 21240608
- BACKGROUNDSie A, Bryan DC, Gaines V, Killebrew LK, Kim CH, Morrison CC, Poller WR, Romilly AP, Schilling K, Sung JH. Multicenter evaluation of the breast lesion excision system, a percutaneous, vacuum-assisted, intact-specimen breast biopsy device. Cancer. 2006 Sep 1;107(5):945-9. doi: 10.1002/cncr.22090. PMID 16874817
- BACKGROUNDMedjhoul A, Canale S, Mathieu MC, Uzan C, Garbay JR, Dromain C, Balleyguier C. Breast lesion excision sample (BLES biopsy) combining stereotactic biopsy and radiofrequency: is it a safe and accurate procedure in case of BIRADS 4 and 5 breast lesions? Breast J. 2013 Nov-Dec;19(6):590-4. doi: 10.1111/tbj.12184. Epub 2013 Sep 19. PMID 24102869
- BACKGROUNDAllen SD, Osin P, Nerurkar A. The radiological excision of high risk and malignant lesions using the INTACT breast lesion excision system. A case series with an imaging follow up of at least 5 years. Eur J Surg Oncol. 2014 Jul;40(7):824-9. doi: 10.1016/j.ejso.2014.03.022. Epub 2014 Apr 2. PMID 24742589