Confocal Histolog Scanner in Routine Breast-Conserving Surgery (CHiB)

NCT06958991 | Recruiting DMC

• 2 other identifiers: 2024-D010120240829
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer Invasive; Breast Cancer Surgery; Lumpectomy; Confocal Laser Endomicroscopy

Keywords

breast cancer surgery; confocal microscopy

Outcome Measures

Primary Outcomes (1)

• Reoperation Rate

  Proportion of women who had a reoperation because of cancer positive margins identified at final pathology assessment.

  From enrollment to the end of treatment (surgery) at 1 month

Secondary Outcomes (4)

• Detection Rate

  1 year

• Usability

  1 year

• Economic Impact

  1 year

• Incidence of adverse device effects

  14 month

Study Arms (1)

Breast Cancer patient with Lumpectomy

EXPERIMENTAL

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.

Device: Histolog Scanner

Interventions

Histolog Scanner DEVICE

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.

Breast Cancer patient with Lumpectomy

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Sex and gender are not a relevant variable in this study because it focuses exclusively on cisgender women with BCS.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Fribourg: lead

Study Sites (1)

HFR

Villars-sûr-glâne, Canton of Fribourg, 1752, Switzerland

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2025
• First Posted: May 6, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 25, 2025

Record last verified: 2025-11

Locations

CH (1)