Diagnostic Imaging Aid for Management of Cervical Lesions (FFC)
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|ClinicalTrials.gov Identifier: NCT02406365|
Recruitment Status : Unknown
Verified April 2015 by Michele Follen, Brookdale University Hospital Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 2, 2015
Last Update Posted : April 10, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer Cervical Intraepithelial Neoplasias Digital Colposcopy Precancerous Cervical Lesions||Device: Diagnostic imaging aid for one-visit management of cervical lesions||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||618 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Development and Application of a Diagnostic Imaging Aid for One-visit Management of Cervical Lesions in Low-resource Settings|
|Study Start Date :||April 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
Experimental: Standard of care plus imaging with research devices
Eligible patients who consent to participate in the research study will receive their standard of care colposcopy or treatment with the Loop Electrosurgical Excision Procedure (LEEP). Additionally, cervical images will be taken using the diagnostic imaging aid. The cervical images will be compared to the histopathology from the biopsies taken as part of the patients' standard of care for colposcopy. If the patient is presenting for the LEEP procedure, then she will be asked if one or two biopsies can be obtained prior to the procedure but after anesthesia has been administered.
The imaging device is not being used to make a diagnosis, but rather to develop an algorithm to make more efficacious and timely diagnoses of cervical neoplasias in the future.
Device: Diagnostic imaging aid for one-visit management of cervical lesions
- Detection of precancerous cervical lesions or cervical cancer [ Time Frame: At point of care for colposcopy or treatment with LEEP (5 minutes). ]Eligible patients who are referred to the colposcopy clinic for a diagnosis following an abnormal Pap smear will be asked to participate in the study. All participating women will receive their standard of care colposcopy as usual. In addition to their routine care, the handheld imaging research device will also be used to capture cervical images. The images will be analyzed and compared to the biopsies obtained. The imaging device will not be used to make a diagnosis. As part of the research study, one or two additional biopsies will be obtained if the patient agrees. These additional biopsies will serve as the control tissue, since they will be taken from tissue that appears normal through the colposcope.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02406365
|Contact: Leonid Fradkin, PhDfirstname.lastname@example.org|
|Contact: Thelma Carrillo, MPHemail@example.com|
|United States, New York|
|Brookdale University Hospital and Medical Center||Not yet recruiting|
|Brooklyn, New York, United States, 11212|
|Contact: Leonid Fradkin, PhD 718-240-8225 firstname.lastname@example.org|
|Contact: Thelma Carrillo, MPH 718-240-5978 email@example.com|
|Principal Investigator: Michele Follen, MD, PhD|
|Principal Investigator:||Michele Follen, PhD||Brookdale University Hospital and Medical Center|