Ignite Creation Date:
2024-07-17 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461663
Status:
COMPLETED
Last Update Posted:
2024-06-17
First Post:
2023-01-09
Brief Title:
CairnSurgical Breast Cancer Locator BCL Post-Market Study
Sponsor:
CairnSurgical Inc
Organization:
CairnSurgical Inc
Study Overview
Official Title:
An Interventional Post-Market Study to Evaluate the Performance of a Custom-made Medical Device Breast Cancer Locator BCL System in Breast-conserving Surgery BCS
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This interventional post-market multicenter clinical investigation is designed to evaluate the performance of a custom-made medical device the Breast Cancer Locator BCL in Subjects with non-palpable breast cancer in Europe
Detailed Description:
The aim of this interventional post-market multicenter clinical investigation is to evaluate the performance of a custom-made medical device the Breast Cancer Locator BCL system in subjects with non-palpable breast cancer The study will be conducted in European countries To evaluate the performance of BCL in reducing the positive margin rate the proportion of patients with positive margins after partial mastectomy with the BCL will be obtained
Each Subject after signing an Informed Consent Form ICF will enter into a screening phase during which several assessments eg demographics medical history evaluation of available prone MRI and core biopsy pathological results will be conducted
At visit 1 the Subject will undergo supine MRI from which a 3D breast image and BCL will be made
At visit 2 the patient will undergo Breast Conserving Surgery BCS using the BCL system On the same day the specimen volume will be determined The excised specimen will be sent to the pathological lab for analysis The results including the positive margin rate PMR and specimen mammogram will be obtained within 14 days
At visit 3 follow-up assessments including physical examination and adverse event review will be performed
At the End Of Study visit adverse events will be assessed and patients will be asked to express their satisfaction with the BREAST-Q
Each Subject after signing an Informed Consent Form ICF will enter into a screening phase during which several assessments eg demographics medical history evaluation of available prone MRI and core biopsy pathological results will be conducted
At visit 1 the Subject will undergo supine MRI from which a 3D breast image and BCL will be made
At visit 2 the patient will undergo Breast Conserving Surgery BCS using the BCL system On the same day the specimen volume will be determined The excised specimen will be sent to the pathological lab for analysis The results including the positive margin rate PMR and specimen mammogram will be obtained within 14 days
At visit 3 follow-up assessments including physical examination and adverse event review will be performed
At the End Of Study visit adverse events will be assessed and patients will be asked to express their satisfaction with the BREAST-Q
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None