Magseed Magnetic Marker Localization
|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: NCT03020888|
Recruitment Status : Active, not recruiting
First Posted : January 13, 2017
Last Update Posted : July 25, 2018
|Condition or disease||Intervention/treatment||Phase|
|Disorders of Breast Breast Lesions||Device: Magseed and Sentimag||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open Label, Post Marketing Study of Magseed and Sentimag in Patients Undergoing Surgical Excision of a Breast Lesion That Requires Preoperative Radiographic Localization|
|Study Start Date :||January 2017|
|Actual Primary Completion Date :||February 2018|
|Estimated Study Completion Date :||October 2018|
Experimental: 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.
Device: Magseed and Sentimag
Magseed marker and Sentimag probe for lesion localization
- Percent retrieval rate of the index lesion and Magseed [ Time Frame: Time of surgery ]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.
- Rates of device-related adverse events [ Time Frame: Up to 8 weeks post surgery ]Rates of device-related adverse events and device-related serious adverse events
- Radiological Ease of Placement [ Time Frame: At time of marker deployment ]Radiologist rated ease of marker placement
- Radiological Placement Accuracy [ Time Frame: At time of marker deployment ]Success rate of Magseed placement relative to the lesion (placement accuracy)
- Surgical Localization - Re-excision [ Time Frame: At time of surgery ]Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion
- Surgical Localization - ease of localization [ Time Frame: At time of surgery ]Surgeon rated ease of localization during surgery
- Surgical Localization - duration of localization [ Time Frame: At time of surgery ]Duration of lumpectomy procedure
- Pathology [ Time Frame: Up to 8 weeks post surgery ]Pathologist rated ease of marker identification and retrieval
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): NCT03020888
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030-4008|