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

NCT ID: NCT02718209

Last Updated: 2016-03-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-04-30

Brief Summary

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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

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Conditions

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Gynecological Malignancies

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Frozen section

Frozen sections taken from women operated on for possible gynecologic malignancies.

Group Type EXPERIMENTAL

Mid-Infrared Spectroscopy with ATR

Intervention Type DEVICE

Interventions

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Mid-Infrared Spectroscopy with ATR

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Women with one or more tumors in reproductive system

Exclusion Criteria

* Pregnant women
* Unable to give consent
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hillel Yaffe Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ilan Bruchim, MD

Role: PRINCIPAL_INVESTIGATOR

Hillel Yaffe Medical Center

Locations

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Hillel Yaffe Medical Center

Hadera, , Israel

Site Status

Countries

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Israel

Central Contacts

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Ilan Bruchim, MD

Role: CONTACT

Facility Contacts

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Ilan Bruchim, MD

Role: primary

Other Identifiers

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HYMC-84-15

Identifier Type: -

Identifier Source: org_study_id

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