An In-vitro Real-time System Based on Tissue Smears to Identify Malignancy During Hysteroscopic Procedure
Sponsor
Hillel Yaffe Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT03971032
Collaborator
(none)
300
1
1
16
18.8
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
300 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Anticipated Study Start Date
:
Dec 31, 2019
Anticipated Primary Completion Date
:
May 1, 2021
Anticipated Study Completion Date
:
May 1, 2021
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Women undergoing hysteroscopy Women presenting with abnormal bleeding, abnormal cervical or uterine findings who have consented to undergo hysteroscopy |
Procedure: Hysteroscopy
Diagnostic procedure
Device: Infrared Spectroscopy
This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy
|
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Patients undergoing hysteroscopy
Exclusion Criteria:
- Pregnancy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hillel Yaffe Medical Center | Hadera | Israel | 38100 |
Sponsors and Collaborators
- Hillel Yaffe Medical Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier:
NCT03971032
Other Study ID Numbers:
- HYMC-0098-18
First Posted:
Jun 3, 2019
Last Update Posted:
Dec 4, 2019
Last Verified:
Dec 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: