Clinical trial · Observational
Exploratory Study Comparing ClearSight System 2D Map to Post Surgery Histopathological Analysis in Lumpectomy
Clinical Study of the ClearSight™ System to Evaluate the Ability to Distinguish Malignant From Non-malignant Breast Tissue by Comparing MR Measurements of Freshly Excised Breast Tissue to Histopathology
NCT02679378CI-TRIAL-00063788completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.
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 |
|---|---|---|---|
| ClearSight™ System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- ClearSight™ System
- description
- To assess the ability of the ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery when compared to histopathological assessment.
- interventionNames
- Device: ClearSight™ System
Primary outcomes (1)
- measure
- Malignant and non-malignant breast tissues will be assessed by ClearSight™ to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery using histopathological assessment as reference
- timeFrame
- 12 months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Women histologically diagnosed with carcinoma of the breast, scheduled for primary lumpectomy (partial mastectomy) procedure. 2. Age ≥18. 3. Signed ICF Exclusion Criteria: 1. Prior surgical procedure in the same breast within 12 months prior to the surgery date. 2. Recurrent breast cancer surgery. 3. Neoadjuvant chemotherapy. 4. Previous radiation therapy to the operated breast. 5. Pregnant / breast feeding. 6. Participating in any other study that might affect results.
References
Publications (0)
Data not yet available
No reference posted for this study.