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The purpose of this study is to show that addition of device use to a routine breast cancer tumor excision procedure is beneficial and assists the surgeon in correctly determining the extent of excision.
The study is a prospective, multi-center, randomized, double arm study demonstrating the effectiveness of the device in adjunctive use for locating the tissue for additional excision following primary specimen excision. One arm is a "Standard of Care" (SOC) Control group and the other arm a "Device+SOC" group.In the "Device +SOC" group the surgeon will use the MarginProbe device on the tissue specimen removed during the surgical procedure.The surgeon will use the results derived from the device and other routine assessments to decide if it is necessary to remove some additional breast tissue.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SOC | Active Comparator | Standard of Care arm - standard of care lumpectomy procedure |
|
| Device + SOC | Experimental | Use of the device in addition to the standard of care lumpectomy procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MarginProbe | Device | Device use to assess margin status of the excised specimen surface. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity. | Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively | two weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tanir M. Allweis, MD | Hadassah Medical Organization, Israel | Principal Investigator |
| Moshe Carmon, MD | Shaare Zedek Medical Center, Israel | Principal Investigator |
| Tami Karni, MD | Assaf Harefeh Medical Center, Israel | Principal Investigator |
| Alison Estabrook, MD | St. Luke's Roosevelt, NY, USA | Principal Investigator |
| Freya Schnabel, MD | NYU Clinical Cancer Center, NY, USA | Principal Investigator |
| Rache M. Simmons, MD | Weill Medical College of Cornell University, NY, USA | Principal Investigator |
| Sheldon M. Feldman, MD | Columbia University Medical Center, NY, USA | Principal Investigator |
| Mark A. Gittelman, MD | Breast Care Specialist, Allentown, Pennsylvania, USA | Principal Investigator |
| Neil Friedman, MD | Mercy Health Srvices, Baltimore, USA |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pacific Breast Care | Costa Mesa | California | 92627 | United States | ||
| University of Southern California |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24595800 | Result | Schnabel F, Boolbol SK, Gittleman M, Karni T, Tafra L, Feldman S, Police A, Friedman NB, Karlan S, Holmes D, Willey SC, Carmon M, Fernandez K, Akbari S, Harness J, Guerra L, Frazier T, Lane K, Simmons RM, Estabrook A, Allweis T. A randomized prospective study of lumpectomy margin assessment with use of MarginProbe in patients with nonpalpable breast malignancies. Ann Surg Oncol. 2014 May;21(5):1589-95. doi: 10.1245/s10434-014-3602-0. Epub 2014 Mar 5. |
| Label | URL |
|---|---|
| Dune Medical Devices official web site | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care (SOC) | Standard of Care arm - standard of care lumpectomy procedure Lumpectomy: Standard of care lumpectomy procedure |
| FG001 | Device + (Standard of Care) SOC |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Lumpectomy |
| Procedure |
Standard of care lumpectomy procedure |
|
| Kristen L. Fernandez, MD | Franklin Square Hospital Center, Baltimore, USA | Principal Investigator |
| Shawna C. Willey, MD | Georgetown University Hospital, Washington, USA | Principal Investigator |
| Lorraine Tafra, MD | Anne Arundel Medical Center, Annapolis, USA | Principal Investigator |
| Karen Lane, MD | UCIrvine Medical Center, California, USA | Principal Investigator |
| Jay Harness, MD | St. Joseph Hospital, California, USA | Principal Investigator |
| Alice Police, MD | Pacific Breast Care, California, USA | Principal Investigator |
| Dennis R. Holmes, MD | University of South California, California, USA | Principal Investigator |
| Scott Karlan, MD | Cedars Sinai Hospital, California, USA | Principal Investigator |
| Stephanie Akbari, MD | Virginia Hospital Center | Principal Investigator |
| Thomas Frazier, MD | Bryn Mawr Hospital | Principal Investigator |
| Lisa E. Guerra, MD | HOAG Memorial Hospital | Principal Investigator |
| Susan K. Boolbol, MD | Beth Israel Medical Center, NY, USA | Principal Investigator |
| Los Angeles |
| California |
| 90033 |
| United States |
| Cedars Sinai Hospital | Los Angeles | California | 90048 | United States |
| HOAG Memorial Hospital | Newport Beach | California | 92658-6100 | United States |
| St. Joseph Hospital | Orange | California | 92868 | United States |
| UCIrvine Medical Center | Orange | California | 92868 | United States |
| Georgetown University Hospital | Washington D.C. | District of Columbia | 20007 | United States |
| Anne Arundel Medical Center | Annapolis | Maryland | 21401 | United States |
| Mercy Hospital Services | Baltimore | Maryland | 21202 | United States |
| Franklin Square Hospital Center | Baltimore | Maryland | 21237 | United States |
| Beth Israel Medical Center | New York | New York | 10003 | United States |
| NYU Clinical Cancer Center | New York | New York | 10016 | United States |
| St. Luke's Roosevelt | New York | New York | 10019 | United States |
| Weill Medical College of Cornell University | New York | New York | 10021 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Breast Care Center | Allentown | Pennsylvania | 18104 | United States |
| Bryn Mawr Hospital | Bryn Mawr | Pennsylvania | 19010 | United States |
| Virginia Hospital Center | Arlington | Virginia | 22205 | United States |
| Haddasah Medical Organization | Jerusalem | Israel |
| Shaare Zedek | Jerusalem | Israel |
| Assaf Harofeh Medical Center | Zrifin | 70300 | Israel |
Use of the device in addition to the standard of care lumpectomy procedure.
MarginProbe: Device use to assess margin status of the excised specimen surface.
Lumpectomy: Standard of care lumpectomy procedure
| FG002 | Roll-in | Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care (SOC) | Standard of Care arm - standard of care lumpectomy procedure Lumpectomy: Standard of care lumpectomy procedure |
| BG001 | Device + (Standard of Care) SOC | Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Primary Effectiveness Endpoint is a Measure of Intraoperative Success in Addressing Positive Margins as Detected by Permanent Pathology)by Additional Oriented Tissue Re-excision From the Surgical Cavity. | Tests the efficacy of the device to intra-operatively assess positive margins (superiority) - CSR is 'positive' when all positive margins, as detected by histology, on the main specimen addressed intra-operatively | The Analysis Set for evaluating intraoperative assessment consisted of patients with at least one histologically positive margin on main lumpectomy specimen ("PSS" - Positive specimen subjects) | Posted | Number | percentage of participants analyzed | two weeks after surgery |
|
|
|
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| Post-Hoc | Re-excision Lumpectomy Procedures Due to Positive Margin on Main Specimens | Posted | Number | percentage of participants | Up to 2 months post-surgery |
|
|
Up to 2 months post-surgery.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard of Care (SOC) | Standard of Care arm - standard of care lumpectomy procedure Lumpectomy: Standard of care lumpectomy procedure | 5 | 298 | 0 | 298 | ||
| EG001 | Device + (Standard of Care) SOC | Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure | 6 | 298 | 0 | 298 | ||
| EG002 | Roll-in | Use of the device in addition to the standard of care lumpectomy procedure. MarginProbe: Device use to assess margin status of the excised specimen surface. Lumpectomy: Standard of care lumpectomy procedure | 3 | 68 | 0 | 68 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infections and infestations | Infections and infestations | Systematic Assessment |
| ||
| Injury, poisoning and procedural complications | Injury, poisoning and procedural complications | Systematic Assessment |
| ||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Reproductive system and breast disorders | Reproductive system and breast disorders | Systematic Assessment |
| ||
| Vascular disorders | Vascular disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Manager | Dune Medical Devices | +97246178000 | shiri@dunemedical.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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| ID | Term |
|---|---|
| D015412 | Mastectomy, Segmental |
| ID | Term |
|---|---|
| D008408 | Mastectomy |
| D013514 | Surgical Procedures, Operative |
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| Male |
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