Clinical trial · Interventional
Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)
Confocal Histolog Scanner in Routine Breast-Conserving Surgery
NCT06958991CI-TRIAL-00097876CHiBrecruitingN/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)
The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.
Conditions
Conditions (4)
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 Invasive | — | UNRESOLVED | — |
| Breast Cancer Surgery | — | UNRESOLVED | — |
| Confocal Laser Endomicroscopy | — | UNRESOLVED | — |
| Lumpectomy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histolog Scanner | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast Cancer patient with Lumpectomy
- description
- The clinical performance study is collecting data from the use of a CE mark product used within the scope of its intended purpose to intraoperatively visualize tissue specimen. The subjects are not submitted to invasive and burdensome procedures compared to the standard of care surgical practices and regular use of the CE mark product.
- interventionNames
- Device: Histolog Scanner
Primary outcomes (1)
- measure
- Reoperation Rate
- timeFrame
- From enrollment to the end of treatment (surgery) at 1 month
- description
- Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.
Secondary outcomes (4)
- measure
- Detection Rate
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Adult female Subject ≥18 years old. * Subject scheduled for breast conserving surgery of invasive and/or in-situ ductal and lobular carcinoma. * Subject is able to read, understand and sign the informed consent. Exclusion Criteria: * Subject with planned mastectomy * Subject does not speak French- Subject with planned tumor-adapted breast reduction * Subject is pregnant/ lactating. Subjects pregnant/lactating are excluded because such subjects are presenting additional risks during the surgery and they are also rare. * Participation in any other clinical study that would affect data acquisition.
References
Publications (0)
Data not yet available
No reference posted for this study.