NCT02718209

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 24, 2016

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

March 24, 2016

Status Verified

March 1, 2016

Enrollment Period

2 years

First QC Date

March 21, 2016

Last Update Submit

March 21, 2016

Conditions

Gynecological Malignancies

Outcome Measures

Primary Outcomes (1)

  • Gynecological Malignancies Identified in Real Time

    Results of Spectroscopy will be compared to frozen section/histopathology findings

    One hour

Study Arms (1)

Frozen section

EXPERIMENTAL

Frozen sections taken from women operated on for possible gynecologic malignancies.

Device: Mid-Infrared Spectroscopy with ATR

Interventions

Mid-Infrared Spectroscopy with ATRDEVICE
Frozen section

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with one or more tumors in reproductive system

You may not qualify if:

  • Pregnant women
  • Unable to give consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Study Officials

  • Ilan Bruchim, MD

    Hillel Yaffe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilan Bruchim, MD

CONTACT

ilanb@hy.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2016

First Posted

March 24, 2016

Study Start

April 1, 2016

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

March 24, 2016

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)