Trials / Completed
CompletedNCT01766284
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
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)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 100 (estimated)
- Sponsor
- Preventive Oncology International, Inc. · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NIRIS 1300e | Optical coherence tomography (OCT) is similar to ultrasound pulse-echo imaging, with optical scatter rather than acoustic reflectivity being measured. OCT employs harmless near-infrared light technology which uses low coherence interferometry to produce an image (based on optical scattering) of tissue microstructure. |
Timeline
- Start date
- 2012-11-01
- Primary completion
- 2012-11-01
- Completion
- 2012-11-01
- First posted
- 2013-01-11
- Last updated
- 2013-02-15
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT01766284. Inclusion in this directory is not an endorsement.