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

March 21, 2016 updated by: Hillel Yaffe Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Hadera, Israel, 38100
        • Hillel Yaffe Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women with one or more tumors in reproductive system

Exclusion Criteria:

  • Pregnant women
  • Unable to give consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Frozen section
Frozen sections taken from women operated on for possible gynecologic malignancies.
Device: Mid-Infrared Spectroscopy with ATR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gynecological Malignancies Identified in Real Time
Time Frame: One hour
Results of Spectroscopy will be compared to frozen section/histopathology findings
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hillel Yaffe Medical Center

Investigators

  • Principal Investigator: Ilan Bruchim, MD, Hillel Yaffe Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

April 1, 2018

Study Completion (Anticipated)

April 1, 2018

Study Registration Dates

First Submitted

March 21, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 24, 2016

Study Record Updates

Last Update Posted (Estimate)

March 24, 2016

Last Update Submitted That Met QC Criteria

March 21, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-84-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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