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

Hillel Yaffe Medical Center300 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

300

Conditions

Uterine Cervical Neoplasm Uterine Neoplasms

Interventions

HysteroscopyPROCEDURE

Diagnostic procedure

Infrared SpectroscopyDEVICE

This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing hysteroscopy Exclusion Criteria: * Pregnancy

Locations (1)

Hillel Yaffe Medical Center

Hadera, Israel

Outcomes

Primary Outcomes

Comparison of infrared spectroscopy with routine histopathology

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.

Time frame: 3 years

Central Contacts

Ilan Bruchim, MD

CONTACT

972-4-7744335 ilanb@hy.health.gov.il

Data from ClinicalTrials.gov

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