Trial Outcomes & Findings for Magseed Magnetic Marker Localization (NCT NCT03020888)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

120 participants

Primary outcome timeframe

Time of surgery on average 16 minutes

Results posted on

2021-02-04

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	120
Overall Study COMPLETED	107
Overall Study NOT COMPLETED	13

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Physician Decision	4
Overall Study Withdrawal by Subject	6
Overall Study Insurance coverage	2
Overall Study Lost to Follow-up	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Magseed and Sentimag n=107 Participants 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
Age, Continuous	60.73 Years STANDARD_DEVIATION 11.58 • n=107 Participants
Sex: Female, Male Female	107 Participants n=107 Participants
Sex: Female, Male Male	0 Participants n=107 Participants
BMI	28.83 kg/m^2 STANDARD_DEVIATION 5.91 • n=107 Participants

PRIMARY outcome

Timeframe: Time of surgery on average 16 minutes

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.

Outcome measures

Outcome measures
Measure	Magseed and Sentimag n=107 Participants 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
Percent of Participants With Retrieval of Index Lesion and Magseed	100 percentage of participants

SECONDARY outcome

Timeframe: 8 weeks

Rates of device-related adverse events and device-related serious adverse events

Outcome measures

Outcome measures
Measure	Magseed and Sentimag n=107 Participants 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
Number of Device Related Adverse Events	0 Number of device related adverse events

SECONDARY outcome

Timeframe: At the time of marker deployment on average 8.39 minutes

Radiologist were asked to rate ease of marker placement graded from Very easy, Fairly Easy \& Difficult after each marker placement.

Outcome measures

Outcome measures
Measure	Magseed and Sentimag n=107 Participants 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
Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy	98 % Participants

SECONDARY outcome

Timeframe: At time of marker deployment on average 8.39 minutes

Population: 107 participants had 124 markers placed

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

Outcome measures

Outcome measures
Measure	Magseed and Sentimag n=124 Markers 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
Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion	95.16 percentage of markers

SECONDARY outcome

Timeframe: During surgery on average 16 minutes

Population: malignant breast lesions

Overall re-excision rate and re-excision rate necessary to remove the Magseed or targeted lesion

Outcome measures

Outcome measures
Measure	Magseed and Sentimag n=98 Participants 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
Percentage of Participants With Re-excision	9 percentage of participants

SECONDARY outcome

Timeframe: At time of surgery on average 16 minutes

Surgeon rated ease of localization during surgery assessed for each procedure as either very easy, fairly easy, fairly difficult, difficult, unable to localise

Outcome measures

Outcome measures
Measure	Magseed and Sentimag n=107 Participants 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
Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy	86.9 percentage of participants

SECONDARY outcome

Timeframe: At time of surgery on average 16 minutes

Duration of the lumpectomy procedure, time taken to remove the lesion

Outcome measures

Outcome measures
Measure	Magseed and Sentimag n=107 Participants 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
Surgical Localization - Duration of Localization	5 minutes Interval 1.0 to 45.0

SECONDARY outcome

Timeframe: On the day of surgery

Pathologist rated ease of marker identification and retrieval as: 1) Unable to retrieve 2) Difficult 3) Fairly difficult 4)fairly easy 5) very easy

Outcome measures

Outcome measures
Measure	Magseed and Sentimag n=107 Participants 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
Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy	96 percentage of participants

Adverse Events

Magseed and Sentimag

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Matthew Womack

Endomag

Phone: +44 7851 247439

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place