Thermal Imaging for Evaluation of the Cervix

Cervical Neoplasia Clinical Trial

Official title:

Thermal Imaging for Cervical Cancer Screening and Early Detection

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02908607
• Other study ID #: 0104-16-MMC
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• First received: September 18, 2016
• Last updated: September 20, 2016
• Start date: November 2016

Study information

• Verified date: September 2016
• Source: Meir Medical Center
• Contact: Yfat Kadan, Dr
• Phone: 972-9-7471575
• Email: yfat_ka[@]clalit.org.il
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• 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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cervical Neoplasia

Intervention

Device:
• Thermal imaging
Examination of the cervix by thermal imaging camera

Locations

Country	Name	City	State
Israel	Meir medical center	Kefar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Meir Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

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