Thermal Imaging for Evaluation of the Cervix

NCT ID: NCT02908607

Last Updated: 2016-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Cervical Neoplasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Thermal imaging

Intervention Type DEVICE

Examination of the cervix by thermal imaging camera

Interventions

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Thermal imaging

Examination of the cervix by thermal imaging camera

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* For group A and B - women that had conization in the past
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Meir Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Yfat kadan

Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Meir medical center

Kfar Saba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Yfat Kadan, Dr

Role: CONTACT

972-9-7471575

Other Identifiers

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0104-16-MMC

Identifier Type: -

Identifier Source: org_study_id

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