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Clinical evaluation of a prototype drop-in gamma probe for sentinel node biopsy

Conditions
prostate cancer sentinel node biopsy
Registration Number
NL-OMON26233
Lead Sponsor
KI-AV
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Other
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

-Patients > 18 years of age;

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

-Patients with a history of iodine allergy;

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
-Determination of the sensitivity of the prototype drop-in probe for (robot-assisted) laparoscopic sentinel node(s) identification. <br /><br>-Determination of the work-ability of the drop-in probe during (robot-assisted) laparoscopic sentinel node biopsy.
Secondary Outcome Measures
NameTimeMethod
-Evaluation of the ease of gripping prototype drop-in probe;<br /><br>-Evaluation of the maneuverability of the prototype drop-in probe;<br /><br>-Identification of (tumor-positive) sentinel node(s). <br>
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