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| Name | Class |
|---|---|
| M.D. Anderson Cancer Center | OTHER |
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The purpose of this post-marketing study is to provide prospective evidence that the Magseed and Sentimag® is effective for lesion localization in patients undergoing surgical excision of a breast lesion and to summarize measures of product safety and performance.
This is a post-market, prospective, open label, single arm study of Magseed and Sentimag in patients undergoing surgical excision of a breast lesion.
Subjects will have the Magseed marker deployed under imaging guidance up to thirty days prior to surgery.
The Magseed marker will be localized using the Sentimag system during surgery and removed with the lesion.
After the lumpectomy procedure, subjects will be evaluated for safety and patient reported outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magseed and Sentimag | Experimental | Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magseed and Sentimag | Device | Magseed marker and Sentimag probe for lesion localization |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Participants With Retrieval of Index Lesion and Magseed | Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery. | Time of surgery on average 16 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Device Related Adverse Events | Rates of device-related adverse events and device-related serious adverse events | 8 weeks |
| Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kelly Hunt, MD | MD Anderson | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030-4008 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Magseed and Sentimag | Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Magseed and Sentimag | Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Percent of Participants With Retrieval of Index Lesion and Magseed | Percent retrieval rate of the index lesion and Magseed in the initial excised specimen. This is defined as the number of subjects in whom the index lesion and Magseed are retrieved in the initial excised specimen divided by the total number of subjects undergoing surgery. | Posted | Number | percentage of participants | Time of surgery on average 16 minutes |
|
Adverse vents data was captured from the time the Magseed was implanted to 8 weeks after it was surgically removed during the index procedure
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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 | Magseed and Sentimag | Magseed marker deployed to mark a breast lesion under imaging guidance up to 30 days prior to surgery. Marker located during surgery using the Sentimag system, and removed with the lesion. Magseed and Sentimag: Magseed marker and Sentimag probe for lesion localization |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Matthew Womack | Endomag | +44 7851 247439 | mwomack@endomag.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 30, 2016 | Aug 12, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2018 | Aug 12, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement.
| At the time of marker deployment on average 8.39 minutes |
| Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion | Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target | At time of marker deployment on average 8.39 minutes |
| Percentage of Participants With Re-excision | Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion | During surgery on average 16 minutes |
| Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy | Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise | At time of surgery on average 16 minutes |
| Surgical Localization - Duration of Localization | Duration of the lumpectomy procedure, time taken to remove the lesion | At time of surgery on average 16 minutes |
| Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy | Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy | On the day of surgery |
| Lost to Follow-up |
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| Years |
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| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| Units |
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| Participants |
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| Secondary | Number of Device Related Adverse Events | Rates of device-related adverse events and device-related serious adverse events | Posted | Number | Number of device related adverse events | 8 weeks |
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| Secondary | Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy | Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy & Difficult after each marker placement. | Posted | Number | % Participants | At the time of marker deployment on average 8.39 minutes |
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| Secondary | Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion | Success rate of Magseed placement relative to the lesion (placement accuracy) measured as <5mm to lesion; 5-10mm to lesion; >10 mm to the target | 107 participants had 124 markers placed | Posted | Number | percentage of markers | At time of marker deployment on average 8.39 minutes | Markers | Markers |
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| Secondary | Percentage of Participants With Re-excision | Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion | malignant breast lesions | Posted | Number | percentage of participants | During surgery on average 16 minutes |
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| Secondary | Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy | Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise | Posted | Number | percentage of participants | At time of surgery on average 16 minutes |
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| Secondary | Surgical Localization - Duration of Localization | Duration of the lumpectomy procedure, time taken to remove the lesion | Posted | Mean | Full Range | minutes | At time of surgery on average 16 minutes |
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| Secondary | Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy | Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy | Posted | Number | percentage of participants | On the day of surgery |
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| 0 |
| 107 |
| 0 |
| 107 |
| 0 |
| 107 |
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