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IGAR-Breast TeleOp Trial

NCT03734432 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2018-11-08

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

IGAR-Breast TeleOp

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.

Sponsors & Collaborators

  • St. Joseph's Healthcare Hamilton

    collaborator OTHER

  • Sunnybrook Health Sciences Centre

    collaborator OTHER

  • McMaster University

    lead OTHER

Principal Investigators

  • Mehran Anvari · Csii/St Joseph's Healthcare Hamilton

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2019-03-31
Completion
2019-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03734432 on ClinicalTrials.gov