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

Sponsor

Medtronic Surgical Technologies (Industry)

Overall Status

Terminated

CT.gov ID

NCT03520127

Collaborator

(none)

176

Enrollment

Locations

17.1

Actual Duration (Months)

25.1

Patients Per Site

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Lesions	Device: Intact Breast Lesion Excision System (BLES)

Study Design

Study Type:

Observational [Patient Registry]

Actual Enrollment :

176 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Sep 27, 2017

Actual Primary Completion Date :

Feb 15, 2019

Actual Study Completion Date :

Feb 28, 2019

Arms and Interventions

Arm	Intervention/Treatment
Females, 18 years of age or older Females, 18 years of age or older, who will undergo the Intact procedure	Device: Intact Breast Lesion Excision System (BLES) Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.

Arm

Intervention/Treatment

Females, 18 years of age or older

Females, 18 years of age or older, who will undergo the Intact procedure

Device: Intact Breast Lesion Excision System (BLES)

Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.

Outcome Measures

Primary Outcome Measures

Lesion BIRADS score [Weeks prior to the Intact procedure]
Diagnostic imaging result
Imaging lesion size [Weeks prior to the Intact procedure]
Measured in mm
Lesion histology [Weeks prior to the Intact procedure]
Lesion biopsy results
Tissue margin (as reported from histology) rate [Weeks after the Intact procedure, up to approximately 12 weeks]
Procedure margin vs. margin size, measured in mm
Underestimation rate [Weeks after the Intact procedure, up to approximately 12 weeks]
Compared to maximum lesion size, measured in mm

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Birmingham Breast Care	Birmingham	Alabama	United States	35205
2	Winship Cancer Institute-Emory St. Joseph's	Atlanta	Georgia	United States	30342
3	Dalton Surgical Group	Dalton	Georgia	United States	30720
4	Metro Surgical Associates Inc.	Lithonia	Georgia	United States	30058
5	Holyoke Medical Center	Holyoke	Massachusetts	United States	01040
6	Nashville Breast Center	Nashville	Tennessee	United States	37203
7	The Breast Center at Chesapeake Regional Healthcare	Chesapeake	Virginia	United States	23320

Sponsors and Collaborators

Medtronic Surgical Technologies

Investigators

Study Director: Lydia Sakakeeny, PhD, Medtronic Surgical Technologies

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medtronic Surgical Technologies

ClinicalTrials.gov Identifier:

NCT03520127

Other Study ID Numbers:

63-10-2356

First Posted:

May 9, 2018

Last Update Posted:

May 16, 2019

Last Verified:

May 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of May 16, 2019