An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure

December 3, 2019 updated by: Hillel Yaffe Medical Center

A Development of an In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure Using FTIR-ATR Spectroscopy

The aim of the current study is to develop a near real-time system using infrared spectroscopy, that will evaluate the histological specimen that was removed from the uterine cavity during the hysteroscopy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

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:

  • Patients undergoing hysteroscopy

Exclusion Criteria:

  • Pregnancy

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
Other: Women undergoing hysteroscopy
Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy
Procedure: Hysteroscopy
Diagnostic procedure
Device: Infrared Spectroscopy
This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of infrared spectroscopy with routine histopathology
Time Frame: 3 years
Tissue smears that have undergone infrared spectroscopy during hysteroscopy will have a different spectral absorption than healthy tissue, thus indicating malignancy. These results will be compared to the results of routine histopathology to determine accuracy of spectroscopy to indicate malignancy.
3 years

Collaborators and Investigators

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

Sponsor

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 (Anticipated)

December 31, 2019

Primary Completion (Anticipated)

May 1, 2021

Study Completion (Anticipated)

May 1, 2021

Study Registration Dates

First Submitted

May 1, 2019

First Submitted That Met QC Criteria

May 29, 2019

First Posted (Actual)

June 3, 2019

Study Record Updates

Last Update Posted (Actual)

December 4, 2019

Last Update Submitted That Met QC Criteria

December 3, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYMC-0098-18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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