The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures

Not Applicable

• Conditions: Gynecological Malignancies
• Interventions: Device: Mid-Infrared Spectroscopy with ATR

• Registration Number: NCT02718209
• Lead Sponsor: Hillel Yaffe Medical Center

Brief Summary

The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-03
• Study First Submitted: 2016-03-21
• Study First Submitted QC: 2016-03-21
• Last Update Submitted: 2016-03-21
• Study First Posted: 2016-03-24
• Last Update Posted: 2016-03-24
• Study Start: 2016-04
• Primary Completion: 2018-04
• Study Completion: 2018-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women with one or more tumors in reproductive system

Exclusion Criteria

• Pregnant women
• Unable to give consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Frozen section	Mid-Infrared Spectroscopy with ATR	Frozen sections taken from women operated on for possible gynecologic malignancies.

Primary Outcome Measures

Name	Time	Method
Gynecological Malignancies Identified in Real Time	One hour	Results of Spectroscopy will be compared to frozen section/histopathology findings

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel