Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Fribourg
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Histolog Scanner
DeviceThe 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Breast Cancer patient with LumpectomyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Reoperation Rate
Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.
Time frame
From enrollment to the end of treatment (surgery) at 1 monthSecondary outcomes
1
Detection Rate
\- Agreement between margin cancerous status of the main surgical specimen and of recuts determined intraoperatively with the HLS and postoperative final pathology assessment using histological slides (sensibility and specificity)
Time frame
1 year2
Usability
\- Usability rates of HLS and accessories: analysis time
Time frame
1 year3
Economic Impact
\- Change in hospital cost per patient with BCS with or without using the HLS and accessories. This will be evaluated by comparing the usual average cost of breast conserving surgeries and the costs related to the use of the HLS during the surgery
Time frame
1 year4
Incidence of adverse device effects
Incidence of adverse device effects during the surgery.
Time frame
14 monthLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
HFRRecruiting1752, Villars-sûr-glâne, Canton of Fribourg
Switzerland
SwitzerlandSponsors and contacts
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Source ClinicalTrials.gov