Thermal Imaging for Evaluation of the Cervix

Clalit Health Services

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Cervical Neoplasia

Treatments: Device: Thermal imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02908607

0104-16-MMC

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

experimental

Experimental group

Description:

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

Treatment:

Device: Thermal imaging