Clinical trial · Interventional
Intraoperative Use of ClearEdge Device in Breast Conserving Surgery
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.
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 |
|---|---|---|---|
| ClearEdge device | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SoC+ClearEdge device - Standard of Care + study device
- description
- Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery plus the use of the study device to assess for breast cancer cells at the the margins
- interventionNames
- Device: ClearEdge device
- type
- NO_INTERVENTION
- label
- SoC - Standard of Care
- description
- Standard assessment of the surgical margins of the excised breast specimen during lumpectomy surgery
Primary outcomes (1)
- measure
- Percentage of subjects with positive margins post-op
- timeFrame
- In the operating room compared to pathology assessment within 1 week post-op
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who are female (genotype) 2. Patients aged above 18 years, inclusive 3. Patients diagnosed with breast DCIS or invasive cancer recommended for lumpectomy procedure 4. Patients treated with neoadjuvant endocrine therapy may be enrolled Exclusion Criteria: 1. Patients currently receiving chemotherapy 2. Patients having prior ipsilateral surgical treatment for breast cancer 3. Patients who have had radiation therapy for ipsilateral breast cancer or for other malignancy that includes breast tissue in the radiation field (e.g. Hodgkin's lymphoma) 4. Patients who have breast implants 5. Patients who are pregnant and/or lactating 6. Patients participating in other breast cancer studies involving surgical treatment to the breast in the past 6 months.
References
Publications (0)
Data not yet available