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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03971032
Other study ID # HYMC-0098-18
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 31, 2019
Est. completion date May 2021

Study information

Verified date December 2019
Source Hillel Yaffe Medical Center
Contact Ilan Bruchim, MD
Phone 972-4-7744335
Email ilanb@hy.health.gov.il
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date May 2021
Est. primary completion date May 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients undergoing hysteroscopy

Exclusion Criteria:

- Pregnancy

Study Design


Intervention

Procedure:
Hysteroscopy
Diagnostic procedure
Device:
Infrared Spectroscopy
This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy

Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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