Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-01-03 @ 10:20 PM
Study NCT ID:
NCT03734432
Status:
UNKNOWN
Last Update Posted:
2018-11-08
First Post:
2018-11-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IGAR-Breast TeleOp Trial
Sponsor:
McMaster University
Organization:
Study Overview
Official Title:
IGAR-Breast Teleoperative Clinical Investigation
Status:
UNKNOWN
Status Verified Date:
2018-11
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IGAR-Breast-TO
Brief Summary:
The aim of this study is to answer the question: can the IGAR-Breast safely and effectively perform teleoperative breast biopsies? This is a prospective, pilot trial. 5-10 participants will be selected by the radiologist and the success of biopsy analyzed. In addition the number of adverse events, device events and procedural deviations will be assessed to determine safety and efficacy.
Detailed Description:
In this prospective clinical trial, patients who present to the breast cancer clinic at one of the primary sites with suspected breast cancer requiring MRI-guided biopsy for diagnosis or staging will be screened consecutively. Patients who meet the inclusion criteria will be approached for consent to participate in the study. Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site. All consenting participants will be followed up for the assessment of the secondary outcome measure.
A total of 5-10 participants will be consented for the pilot investigation.
Each individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date.
A total of 5-10 participants will be consented for the pilot investigation.
Each individual subject's participation is estimated to last approximately one week post procedure, with the trial itself expected to be completed within one year of its start date.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: