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Completed

NCT Number: NCT03020888

Magseed Magnetic Marker Localization

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.

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Key information

Conditions

Disorders of Breast Breast Diseases Breast Lesions Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030-4008, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects with a breast lesion requiring image-guided localization prior to excision.
  • Subjects aged 18 years or more at the time of consent.

Exclusion criteria

  • The subject is pregnant or lactating.
  • Subject has pacemaker or other implantable device in the chest wall.
  • Subject has current active infection at the implantation site in the breast (per investigatordiscretion)

Treatment and study plan

Magseed and Sentimag

Device

Magseed marker and Sentimag probe for lesion localization

Primary outcomes

  1. Percent of Participants With Retrieval of Index Lesion and Magseed

    Time frame: 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.

Secondary outcomes

  1. Number of Device Related Adverse Events

    Time frame: 8 weeks

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

  2. Percent of Participants With Radiological Ease of Placement Rated as Very Easy, or Fairly Easy

    Time frame: 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.

  3. Percentage of Markers With Radiological Placement Accuracy Measured as <5mm to Lesion

    Time frame: At time of marker deployment on average 8.39 minutes

    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

  4. Percentage of Participants With Re-excision

    Time frame: During surgery on average 16 minutes

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

  5. Percent of Participants With Surgical Ease of Localization - Rated Fairly or Very Easy

    Time frame: 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

  6. Surgical Localization - Duration of Localization

    Time frame: At time of surgery on average 16 minutes

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

  7. Percentage of Participants With Marker Retrieval Rated as Fairly or Very Easy

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Endomagnetics Inc

Industry

Collaborators

  • M.D. Anderson Cancer Center

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 13, 2017
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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