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

Hillel Yaffe Medical Center1 site in 1 country300 target enrollmentDecember 31, 2019

ConditionsUterine Cervical Neoplasm Uterine Neoplasms

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Uterine Cervical Neoplasm
Sponsor: Hillel Yaffe Medical Center
Enrollment: 300
Locations: 1
Primary Endpoint: Comparison of infrared spectroscopy with routine histopathology
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 31, 2019

End Date

May 2021

Last Updated

6 years ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Hillel Yaffe Medical Center

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients undergoing hysteroscopy

Exclusion Criteria

•Pregnancy

Outcomes

Primary Outcomes

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.