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SentiMag® Intraoperative Comparison in Breast Cancer

NCT02336737 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2020-11-23

Study results available
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Summary

The purpose of this pivotal study is to provide prospective evidence that the SentiMag®/SiennaXP® is safe and non-inferior to the current standard of care for lymph node localization in patients with breast cancer as part of a sentinel lymph node biopsy (SLNB) procedure and to summarize measures of product safety and performance.

Conditions

Interventions

DEVICE

SiennaXP

Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe

DRUG

Technetium Tc99m Sulfur Colloid

Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)

DRUG

Isosulfan blue dye

Injection of a single dose of isosulfan blue dye

Sponsors & Collaborators

  • Regulatory and Clinical Research Institute Inc

    collaborator OTHER

  • Endomagnetics Inc

    lead INDUSTRY

Principal Investigators

  • Michael D Alvarado, MD · University of CA, San Francisco Carol Franc Buck Breast Care, Dept of Surgery

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02336737 on ClinicalTrials.gov