Cervical Intraepithelial Neoplasia
Conditions
Keywords
Cervical Lesion, Intraepithelial dysplasia, Human Papillomavirus (HPV), CervImage
Brief summary
The purpose of this study is to evaluate the design and engineering of a new minimally invasive medical imaging device (CervImage™). Investigators are trying to find out if CervImage™ is reliable and easy to use to obtain clinical 3D photographs and to record 3D measurements in human cervixes. Investigators then plan to use these images to determine if CervImage™ design and engineering improvements need to be made.
Detailed description
This study intends to evaluate the design and engineering of an innovative, minimally invasive, 3D, and medical imaging device (CervImage™) for detecting cervical lesions. The research procedure and evaluation will be incorporated into the scheduled annual pap smear exam or colposcopic gynecologic exam that involves using a vaginal speculum. The CervImage™ camera will be positioned within the speculum approximately 1-2 cm distal to the cervix. It will not come into physical contact with the participant. Data collection with the CervImage TM imaging device is expected to take less than 5 minutes. The study will generate live cervical images and gather qualitative feedback from both clinicians and participants. CervImage™ is not a diagnostic product, and this study will not be generating any efficacy or imaging data to be used for diagnostic or therapeutic purposes. If any abnormalities are observed in the CervImage™ procedure described, they will be further evaluated by the Principal Investigator. This will take place during the participant's routine gynecologic exam with colposcopy included as part of their scheduled clinical visit. The device will not be used for diagnostic purposes or for making any clinical decisions or recommendations.
Interventions
DEVICECervImage device
CervImage™, developed by Pensievision, Inc., is an accessible, simple, cost-effective, early detection imaging technology for preventing cervical cancer deaths caused by a lack of screening. The novel device is a simple-to-operate, point-of-care, all-focus, 3D-imaging device, with clinical relevance to early-stage detection and prevention of cervical cancers. CervImage's proprietary 3D-rendering software, incorporating strategies previously used for high resolution imaging with NASA telescopes, can quantify tissue color, volume and shape. Virtual navigation tools and all-focus imaging enable straightforward use by minimally trained personnel; expert personnel can also benefit from shorter setup times. The research procedure and evaluation will be incorporated into the scheduled annual pap smear exam or colposcopic gynecologic exam that involves using a vaginal speculum.
Sponsors
Carilion Clinic
National Cancer Institute (NCI)
Pensievision, Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Single-center, pilot study of the CervImage \[Pensievision, San Diego, CA\] device utilizing an (1) human papillomavirus (HPV) or Intraepithelial dysplasia (CIN) group and (2) no-HPV/CIN group with a single study intervention \[CervImage device\] for collection of quantitative data regarding imaging quality over the standard-of-care imaging modality and qualitative feedback from physician and subject.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Patient 21 to 70 years of age at screening * Patients with known HPV infection or cervical intraepithelial neoplasia (16 patients) * Healthy patients without history of HPV/CIN (2 patients) * Participants able to consent for themselves
Exclusion criteria
* Cognitive Impairment * Currently Pregnant * Incarcerated Individual * Any condition which in the clinical judgement of the PI makes the subject unsuitable or unsafe for study enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Image Quality and Resolution vs Standard-of-Care | Immediately after the procedure | CervImage images evaluated on Spatial resolution, distortion, brightness, magnification, color correctness, corrupted pixel rows, and visual inspection vs standard-of-care cervical imaging for intraepithelial dysplasia \[CIN\] visualization. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Obtain Images | Immediately after the procedure | Time required by the physician to obtain cervical images needed with the CervImage device vs standard-of-care device. |
| Comfort/Discomfort of Subject | Immediately after the procedure | Subjective assessment of discomfort \[and comfort\] with using the CervImage device vs standard-of-care device for colposcopy, by the subject through use of a quantitative questionnaire with a scale of 1 to 10 with 1 being no pain and 10 being extremely painful. |
| Physician Satisfaction | Immediately after the procedure | Overall satisfaction with use of the CervImage device vs standard-of-care device by physician using a quantitative questionnaire with a scale of 1 to 10 with 1 being dissatisfied and 10 being completely satisfied. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORIsaiah Johnson, MD
Carilion Clinic
Outcome results
None listed