The Development of an In-vitro System to Identify Gynecologic Cancer Cells During Surgical Procedures

Gynecological Malignancies Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02718209
• Other study ID #: HYMC-84-15
• Status: Not yet recruiting
• Phase: N/A
• First received: March 21, 2016
• Last updated: March 21, 2016
• Start date: April 2016
• Est. completion date: April 2018

Study information

• Verified date: March 2016
• Source: Hillel Yaffe Medical Center
• Contact: Ilan Bruchim, MD
• Email: ilanb[@]hy.health.gov.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to examine the efficacy of mid-infrared spectroscopy together with Attenuated Total Reflection (ATR), for the detection of gynecological malignancies in real time during surgery.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women with one or more tumors in reproductive system

Exclusion Criteria:

• Pregnant women

• Unable to give consent

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gynecological Malignancies

Intervention

Device:
• Mid-Infrared Spectroscopy with ATR

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	Gynecological Malignancies Identified in Real Time	Results of Spectroscopy will be compared to frozen section/histopathology findings	One hour	No