An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure
Primary Purpose
Uterine Cervical Neoplasm, Uterine Neoplasms
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hysteroscopy
Infrared Spectroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Uterine Cervical Neoplasm
Eligibility Criteria
Inclusion Criteria:
- Patients undergoing hysteroscopy
Exclusion Criteria:
- Pregnancy
Sites / Locations
- Hillel Yaffe Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Women undergoing hysteroscopy
Arm Description
Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03971032
First Posted
May 1, 2019
Last Updated
December 3, 2019
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03971032
Brief Title
An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure
Official Title
A Development of an In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure Using FTIR-ATR Spectroscopy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 31, 2019 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Neoplasm, Uterine Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Women undergoing hysteroscopy
Arm Type
Other
Arm Description
Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy
Intervention Description
Diagnostic procedure
Intervention Type
Device
Intervention Name(s)
Infrared Spectroscopy
Intervention Description
This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy
Primary Outcome Measure Information:
Title
Comparison of infrared spectroscopy with routine histopathology
Description
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.
Time Frame
3 years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients undergoing hysteroscopy
Exclusion Criteria:
Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ilan Bruchim, MD
Phone
972-4-7744335
Email
ilanb@hy.health.gov.il
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ilan Bruchim, MD
Email
ilanb@hy.health.gov.il
First Name & Middle Initial & Last Name & Degree
Ilan Bruchim, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure
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