Thermal Imaging for Evaluation of the Cervix | NCT02908607

Studies
Thermal Imaging for Evaluation of the Cervix

NCT02908607

Sponsor

Meir Medical Center

Status

Unknown status

Last Update Posted

Sep 21, 2016Estimated

Enrollment

40Estimated

Phase

Phase 1Phase 2

Conditions

Cervical Neoplasia

Interventions

Thermal imaging

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2016

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016

Primary Completion Date

Mar 2019Estimated

Completion Date

Not provided

First Submitted Date

Sep 18, 2016

First Submission Date that Met QC Criteria

Sep 20, 2016

First Posted Date

Sep 21, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 20, 2016

Last Update Posted Date

Sep 21, 2016Estimated

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
experimental	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	Device: Thermal imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Thermal imaging	Device	Examination of the cervix by thermal imaging camera	experimental

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The rate of identification of premalignant and malignant lesions of the cervix by thermal imaging		2 years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Yfat Kadan, Dr	Contact	972-9-7471575		yfat_ka@clalit.org.il

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Meir medical center		Kfar Saba			Israel