Clinical trial · Interventional
PEAK PlasmaBlade™ 4.0 Versus Traditional Electrosurgery in Lumpectomy
A Prospective, Randomized, Controlled Study to Evaluate Use of the PEAK PlasmaBladeTM 4.0 in Breast Lumpectomy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Termination due to acquisition of PEAK Surgical by Medtronic
Summary
Brief summary (as posted)
The purpose of this clinical study is to quantify the difference in thermal injury depth at the surgical margin in breast lumpectomy specimens excised with the PlasmaBlade; to subjectively assess histopathologic sample quality metrics; to examine the role that electrosurgical artifact may play in revision lumpectomy procedures; and to compare these endpoints to the standard of care (SOC) technology.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PEAK PlasmaBlade | Device | — | UNRESOLVED |
| Traditional Electrosurgery with scalpel | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PlasmaBlade
- description
- The entirety of the lumpectomy will be performed with the PEAK PlasmaBlade, including the skin incision.
- interventionNames
- Device: PEAK PlasmaBlade
- type
- ACTIVE_COMPARATOR
- label
- SOC
- description
- The SOC consists of scalpel for the skin incision and traditional electrosurgery for the entirety of the subcutaneous dissection.
- interventionNames
- Procedure: Traditional Electrosurgery with scalpel
Primary outcomes (1)
- measure
- Histological Metrics: Amount of Overlying Adherent Char on Slide; Damage to Tumor Epithelium; Effect of Electrosurgical Damage on Diagnostic Quality of Lumpectomy Specimen
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 and 90 years old 2. Physically healthy, stable weight 3. Requiring lumpectomy with wire localization for suspected or confirmed malignant breast disease. 4. Subject must understand the nature of the procedure and provide written informed consent prior to the procedure. 5. Subject must be willing and able to comply with all follow-up evaluations Exclusion Criteria: 1. Age younger than 18 or greater than 90 years old 2. Infection (local or systemic) 3. Cognitive impairment or mental illness 4. Severe cardiopulmonary deficiencies 5. Unable to follow instructions or complete follow-up 6. Currently taking any medication known to affect healing 7. Currently enrolled in another investigational device or drug trial
References
Publications (0)
Data not yet available