Cervical Neoplasia Clinical Trial
Official title:
Thermal Imaging for Cervical Cancer Screening and Early Detection
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.
Status | Not yet recruiting |
Enrollment | 40 |
Est. completion date | |
Est. primary completion date | March 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Israel | Meir medical center | Kefar Saba |
Lead Sponsor | Collaborator |
---|---|
Meir Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging | 2 years | No |
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