Clinical trial · Interventional
Feasibility Study of Cavity Radiofrequency Ablation in ex Vivo Mastectomy Breast Tissue
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was withdrawn from the IRB and never opened. No subjects were enrolled.
Summary
Brief summary (as posted)
The purpose of this study is to build a device that will consistently ablate (destroy or remove) cavitary breast tissue after a formal breast cancer resection in order to mimic the tissue that is now irradiated after breast cancer lumpectomy. The device would be easier to handle, perform the ablation in less time and by so ablating this margin would avoid the need in many for reoperation to obtain negative margins and based on preliminary data avoid the need for radiation. This would be especially important in poor and rural patients and would lead to decreased costs of treatment in patients with favorable breast cancer.
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 |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RFA Applicator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Bi-lateral mastectomy
- interventionNames
- Device: RFA Applicator
Primary outcomes (1)
- measure
- Ablation Depth
- timeFrame
- One year
- description
- Ablation depth is the extent to which tissue has been completely desiccated from the wall of the cavity. It will be assessed by pathologic analysis using H\&, PCNA, and Ki67 stains. The ablation depth of each slide processed is to be the smallest distance of completely necrotic tissue.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Female * Age greater than or equal to 18 years. * Receiving bi-lateral mastectomy due to tumor in the breast, or by choice (prophylactic mastectomy). Only non-cancerous breast tissue will be included in the study. * Ability to understand and the willingness to sign a written informed consent. Exclusion Criteria: * Those determined by the study investigator to have mental, physical, or medical conditions that would indicate that they should not participate. * Because there is no patient contact with the device no medical contraindications are foreseen.
References
Publications (0)
Data not yet available