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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03971032

Enrollment

300

Registered

2019-06-03

Start date

2019-12-31

Completion date

2021-05-31

Last updated

2019-12-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Neoplasm, Uterine Neoplasms

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.

Interventions

PROCEDUREHysteroscopy

Diagnostic procedure

DEVICEInfrared Spectroscopy

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients undergoing hysteroscopy

Exclusion criteria

* Pregnancy

Design outcomes

Primary

Measure	Time frame	Description
Comparison of infrared spectroscopy with routine histopathology	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.

Countries

Israel

Contacts

Primary ContactIlan Bruchim, MD

ilanb@hy.health.gov.il972-4-7744335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026