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Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis

H

Hillel Yaffe Medical Center

Status

Enrolling

Conditions

IVF
Endometritis

Treatments

Device: Infrared Spectroscopy
Procedure: Hysteroscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT04197167
0122-19-HYMC

Details and patient eligibility

About

The Investigator propose to develop an in-vitro technique for the measurement and analysis of freshly excised biopsies during hysteroscopy procedure in patients with suspected Chronic Endometritis (CE) condition. Furthermore, the investigator propose to develop a discrimination model between the CE and inflammatory CE types using the measured spectroscopic data from freshly excised biopsies.

Full description

It is common practice that, following hysteroscopy, the clinician needs to wait for about two weeks before the results of the histology are returned and the clinical treatment is initiated. In this research, the investigator intent to show that the mid infrared ATR (Assisted Reproductive Treatment) spectroscopy method will provide the physician with sufficient information about the CE inflammation status in a considerably shorter period of time to allow immediate initiation of the appropriate treatment.

Enrollment

120 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
  • Patients scheduled for any histological evaluation including endometrial biopsy, dilatation and curettage (D&C), biopsy/excision of uterine polyp or fibroid or any other cervical or uterine lesion.
  • Age 18 and over.

Exclusion criteria

  • Pregnant women, minors and lack of judgment women will not included
  • At the request of the examined woman

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

Women undergoing hysteroscopy
Experimental group
Description:
Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
Treatment:
Procedure: Hysteroscopy
Device: Infrared Spectroscopy

Trial contacts and locations

1

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Central trial contact

Einat Shalom-Paz, Prof; Asaf Bilgory, MD

Data sourced from clinicaltrials.gov

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