Clinical trial · Interventional
In Vitro Detection of Tissue Abnormality
NCT01209182CI-TRIAL-00061177completedN/AClinicalTrials.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)
Intraoperative ex-vivo use of the ClearEdge Imaging Device in Breast Conserving Surgery to image the excised tissue surgical margins. The study is designed to demonstrate reduction in the need for repeat surgeries after breast conserving surgeries by using the ClearEdge as an adjunct imaging device to the standard of care.
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Testing a new device (LS BioPath TOUCH) on excised tissue | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Device image reading
- description
- Tissue images generated by the device are read by surgeons to determine if the tissue area under test has abnormal component or not. When Images generated by the device are read by surgeons as abnormal an additional margin of tissue is removed. The new margin is also imaged by the device to ensure complete tumor excision.
- interventionNames
- Device: Testing a new device (LS BioPath TOUCH) on excised tissue
Primary outcomes (1)
- measure
- •Accuracy of LS BioPath TOUCH device compared to pathology
- timeFrame
- 1 week after surgery
- description
- Assess percentage of FP and FN of test device results compared to pathology results
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Patients aged 25-80 who are scheduled for surgical excision of tissue. Exclusion Criteria: * No prior history of surgery at location of current surgery.
References
Publications (0)
Data not yet available
No reference posted for this study.