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Exploratory Study Comparing ClearSight System 2D Map to Post Surgery Histopathological Analysis in Lumpectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02679378
Recruitment Status : Unknown
Verified August 2017 by Clear Cut Medical Ltd..
Recruitment status was:  Recruiting
First Posted : February 10, 2016
Last Update Posted : August 21, 2017
Sponsor:
Information provided by (Responsible Party):
Clear Cut Medical Ltd.

Brief Summary:
Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

Condition or disease Intervention/treatment
Breast Cancer Device: ClearSight™ System

Detailed Description:
This study is a multicenter, non-randomized, cross-sectional comparative exploratory study comparing the ClearSight System 2D map results to post surgery histopathological analysis of excised mass in lumpectomy surgery. The Efficacy Objective is to assess the ability of the ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery using histopathological assessment as reference. The Safety Objective is that all adverse events, serious adverse events (SAE) will be reported according to local regulations. The actual reporting is discussed in section 0. No device-related adverse events are expected. For more information please refer to the Investigator Brochure.

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Study Type : Observational
Estimated Enrollment : 220 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Clinical Study of the ClearSight™ System to Evaluate the Ability to Distinguish Malignant From Non-malignant Breast Tissue by Comparing MR Measurements of Freshly Excised Breast Tissue to Histopathology
Study Start Date : October 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
ClearSight™ System
To assess the ability of the ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery when compared to histopathological assessment.
Device: ClearSight™ System
comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.




Primary Outcome Measures :
  1. Malignant and non-malignant breast tissues will be assessed by ClearSight™ to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery using histopathological assessment as reference [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   WOMEN
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with primary breast cancer
Criteria

Inclusion Criteria:

  1. Women histologically diagnosed with carcinoma of the breast, scheduled for primary lumpectomy (partial mastectomy) procedure.
  2. Age ≥18.
  3. Signed ICF

Exclusion Criteria:

  1. Prior surgical procedure in the same breast within 12 months prior to the surgery date.
  2. Recurrent breast cancer surgery.
  3. Neoadjuvant chemotherapy.
  4. Previous radiation therapy to the operated breast.
  5. Pregnant / breast feeding.
  6. Participating in any other study that might affect results.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02679378


Contacts
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Contact: Iris Szwarcfiter : +972-8-6326004 iris@clrcut.com

Locations
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United States, Arkansas
University of Arkansas for Medical Sciences Completed
Little Rock, Arkansas, United States, 72205
United States, District of Columbia
The George Washington University Hospital (GWU) Recruiting
Washington, D.C., District of Columbia, United States, 20037
Contact: Dr. Christine B. Teal, Dr.    202-741-3270    cteal@mfa.gwu.edu   
Israel
Kaplan Medical Center Recruiting
Rehovot, Israel
Contact: Tanir Allweis, MD    (972)89441693    tanirallweis@gmail.com   
Assuta Medical Center Completed
Tel Aviv, Israel
Assaf Harofeh Medical Center Completed
Zerifin 70300, Israel
Sponsors and Collaborators
Clear Cut Medical Ltd.
Investigators
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Principal Investigator: Dr. Christine B. Teal, Dr. The George Washington University (GWU)
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Responsible Party: Clear Cut Medical Ltd.
ClinicalTrials.gov Identifier: NCT02679378    
Other Study ID Numbers: 710CLD Rev. 02
First Posted: February 10, 2016    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided