Brief Title
Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix
Official Title
Study of the Diagnostic Efficacy of "Real Time" Niris 1300e Optical Coherence Tomography (OCT) Imaging System in the Management of Pre-invasive and Invasive Neoplasia of the Uterine Cervix (PUSHOCTII)
Brief Summary
Optical Coherence Tomography (OCT) is a technology using harmless near infra-red light
scatter to produce an image. Prior studies with OCT have demonstrated that OCT of the uterine
cervix can differentiate between grades of pre-invasive and invasive cervical disease and
cancer. This study will evaluate the ability of the NIRIS 1300e imaging (OCT) system to
detect pre-invasive cervical disease and cervical cancer.
Detailed Description
B. Specific Aims
1. Primary. To determine the sensitivity, specificity, positive and negative predictive
values for Niris 1300e OCT enhanced gynecologic examination (VIA-OCT
vs.colposcopy-biopsy) for the detection of lesions equal or greater than cervical
intraepithelial neoplasia II (CIN II) and cancer in a "real time" clinical evaluation.
2. Secondary. To examine the ease of use of Niris 1300e OCT in a real time clinical setting
in order to assess its potential application during a "see and treat" or "single episode
of care" clinic visit.
Study Type
Interventional
Primary Outcome
To determine the accuracy of VIA plus Niris 1300e OCT enhanced gynecologic examination.
Secondary Outcome
To compare OCT image (Niris 1300e) technology directly to colposcopy with biopsy for the detection of lesions equal or greater than cervical intraepithelial neoplasia II (CIN II) and cancer in a "real time" clinical evaluation.
Condition
Cervical Intraepithelial Neoplasia
Intervention
NIRIS 1300e
Study Arms / Comparison Groups
Niris 1300e OCT imaging
Description: OCT imaging of the cervix using Niris 1300e will include computer aided calculations for epithelial brightness.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
100
Start Date
November 2012
Completion Date
November 2012
Primary Completion Date
November 2012
Eligibility Criteria
Inclusion Criteria:
1. Female subjects > 18 years of age
2. Subject must voluntarily sign a Patient Informed Consent Form specific to the study.
3. Subject must be physically and mentally willing to comply with all study requirements,
especially conduct of a colposcopy exam.
4. Participant must be attending the Center for Cervical Diagnosis.
Exclusion Criteria:
1. Based on clinical history, physical exam and patient presentation, the subject is
unable to provide adequate informed consent and/or comply with the study requirements.
2. Subject is a prisoner.
3. Subject is pregnant.
4. Subject has had a hysterectomy
5. Subject has received prior pelvic radiotherapy.
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Jerome L Belinson, MD, ,
Location Countries
China
Location Countries
China
Administrative Informations
NCT ID
NCT01766284
Organization ID
PUSHOCTII
Responsible Party
Sponsor
Study Sponsor
Preventive Oncology International, Inc.
Collaborators
Imalux
Study Sponsor
Jerome L Belinson, MD, Principal Investigator, Preventive Oncology International
Verification Date
February 2013