NCT02908607

Brief Summary

When screening results for cervical premalignant lesions are positive, colposcopy is recommended. This is highly sensitive screening method. However, specificity of the test is of low. Thus, a technology that improves the accuracy of the colposcopic exam is needed. This is a feasibility study with the goal of examining the performance of a thermal imaging camera in the detection of cervical malignant and premalignant lesions.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_1

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
Last Updated

September 21, 2016

Status Verified

September 1, 2016

Enrollment Period

2.3 years

First QC Date

September 18, 2016

Last Update Submit

September 20, 2016

Conditions

Cervical Neoplasia

Outcome Measures

Primary Outcomes (1)

  • The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging

    2 years

Study Arms (1)

experimental

EXPERIMENTAL

3 groups of patients will be participated: women with cancer, women with premalignant lesions and women with a normal cervix. All patients will undergo the same examination

Device: Thermal imaging

Interventions

Thermal imagingDEVICE

Examination of the cervix by thermal imaging camera

experimental

Eligibility Criteria

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

You may qualify if:

  • Age \> 18
  • Women with premalignant cervical lesions who are candidates for conization (group A)
  • Women with a normal cervix who are candidates for hysterectomy (group B)
  • Women with newly diagnosed cervical cancer

You may not qualify if:

  • For group A and B - women that had conization in the past

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir medical center

Kfar Saba, Israel

Location

Central Study Contacts

Yfat Kadan, Dr

CONTACT

972-9-7471575yfat_ka@clalit.org.il

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr.

Study Record Dates

First Submitted

September 18, 2016

First Posted

September 21, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2019

Last Updated

September 21, 2016

Record last verified: 2016-09

Locations

IL(1)