NCT03971032

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 3, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

December 31, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

December 4, 2019

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

May 1, 2019

Last Update Submit

December 3, 2019

Conditions

Uterine Cervical NeoplasmUterine Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 years

Study Arms (1)

Women undergoing hysteroscopy

OTHER

Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy

Procedure: HysteroscopyDevice: Infrared Spectroscopy

Interventions

HysteroscopyPROCEDURE

Diagnostic procedure

Women undergoing hysteroscopy
Infrared SpectroscopyDEVICE

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

Women undergoing hysteroscopy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing hysteroscopy

You may not qualify if:

  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Neoplasms

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and GynecologicalDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalMinimally Invasive Surgical ProceduresSurgical Procedures, OperativeObstetric Surgical ProceduresGynecologic Surgical ProceduresUrogenital Surgical Procedures

Central Study Contacts

Ilan Bruchim, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2019

First Posted

June 3, 2019

Study Start

December 31, 2019

Primary Completion

May 1, 2021

Study Completion

May 1, 2021

Last Updated

December 4, 2019

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)