In Vitro Detection of Tissue Abnormality

Breast Cancer Female Clinical Trial

Official title:

In Vitro Detection of Tissue Abnormality

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01209182
• Other study ID #: LSB-01
• Status: Completed
• Phase: N/A
• Start date: October 15, 2010
• Est. completion date: January 9, 2012

Study information

• Verified date: April 2022
• Source: LS BioPath
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

Intraoperative real-time margin assessment of breast conserving surgeries can reduce the need for repeat operations due to cancer involved margins. Repeat operations result in excessive removal of benign tissue, increased risk for infection, slower healing and inferior cosmetic results. In the current standard of care, the status of the margins is determined by pathology only several days after surgery. An intraoperative assessment of the margins enables complete tumor excision in a single surgery.

The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.

ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: January 9, 2012
• Est. primary completion date: December 13, 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Congenital Abnormalities

Intervention

Device:
• Testing a new device (LS BioPath TOUCH) on excised tissue
Measurements are obtained with test device on excised tissue.

Locations

Country	Name	City	State
United States	St. Mary's	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
LS BioPath

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	•Accuracy of LS BioPath TOUCH device compared to pathology	Assess percentage of FP and FN of test device results compared to pathology results	1 week after surgery