Thermal Imaging for Evaluation of the Cervix

Phase 1

• Conditions: Cervical Neoplasia
• Interventions: Device: Thermal imaging

• Registration Number: NCT02908607
• Lead Sponsor: Meir Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-18
• Study First Submitted QC: 2016-09-20
• Last Update Submitted: 2016-09-20
• Study First Posted: 2016-09-21
• Last Update Posted: 2016-09-21
• Study Start: 2016-11
• Primary Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental	Thermal imaging	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

Primary Outcome Measures

Name	Time	Method
The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging	2 years

Trial Locations

Locations (1)

Meir medical center; 🇮🇱 Kefar Saba, Israel