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

Not Applicable

• Conditions: Uterine Neoplasms; Uterine Cervical Neoplasm
• Interventions: Procedure: Hysteroscopy; Device: Infrared Spectroscopy

• Registration Number: NCT03971032
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-05-01
• Study First Submitted QC: 2019-05-29
• Study First Posted: 2019-06-03
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-03
• Last Update Posted: 2019-12-04
• Study Start: 2019-12-31
• Primary Completion: 2021-05
• Study Completion: 2021-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Patients undergoing hysteroscopy

Exclusion Criteria

• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women undergoing hysteroscopy	Hysteroscopy	Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy
Women undergoing hysteroscopy	Infrared Spectroscopy	Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel