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Evaluation of Intraoperative Usage of Sentinella in Detecting Sentinel Lymph Nodes

NCT02416336 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2017-04-05

No results posted yet for this study

Summary

The aim of this study is to investigate whether the Sentinella camera improves intraoperative detection and removal of sentinel lymph nodes (SLNs) when used in conjunction with standard detection methods. Of primary interest is whether the Sentinella camera identifies additional tumor-positive SLNs that are missed using traditional imaging techniques. Other outcomes related to the standard of care use of the Sentinella camera may also be assessed.

Conditions

Interventions

DEVICE

Sentinella Intraoperative imaging protocol

There is a "holding" time of 15-20 minutes after the lymph node is removed during which the node is further dissected, examined and prepared for pathological analysis. This occurs before the procedure is completed in case the surgeon determines that further surgical exploration or tissue removal is required. In this study, the investigators will use this holding time to collect images of the sentinel lymph node area using the Sentinella camera for this study. Therefore, participation in this study will not increase the subject's overall procedure time. However, if the Sentinella camera detects something that the standard imaging techniques have missed, such as an additional sentinel node, the surgeon will do further exploration and tissue removal as needed.

Sponsors & Collaborators

  • California Pacific Medical Center

    collaborator OTHER

  • Oncovision Inc

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-31
Primary Completion
2017-03-31
Completion
2017-03-31

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 NCT02416336 on ClinicalTrials.gov