A Registry Study Evaluating Outcomes in Breast Biopsy With the Intact™ Breast Lesion Excision System (BLES)

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Medtronic

Status

Terminated

Conditions

Breast Lesions

Treatments

Device: Intact Breast Lesion Excision System (BLES)

Study type

Observational

Funder types

Industry

Identifiers

NCT03520127
63-10-2356

Details and patient eligibility

About

The purpose of this registry study is to collect use and clinical outcomes data following breast lesion excision or sampling with the Intact BLES.

Enrollment

176 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Female
  • Age ≥ 18 years
  • BIRADS ≤ 5, as initially imaged
  • Subject is willing and capable of providing informed consent and has a scheduled or planned breast lesion excision or sampling where the Intact BLES is expected to be used

Exclusion criteria

  • Male
  • Subjects with subglandular (pre-pectoral, or "single plane") breast implants
  • Subjects with electronic implantable devices (such as pacemakers and defibrillators)
  • Subjects who are contraindicated for surgery due to factors such as anti-coagulant use which cannot be safely reversed

Trial design

176 participants in 1 patient group

Females, 18 years of age or older
Description:
Females, 18 years of age or older, who will undergo the Intact procedure
Treatment:
Device: Intact Breast Lesion Excision System (BLES)

Trial contacts and locations

7

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Data sourced from clinicaltrials.gov

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