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ACTIVE NOT RECRUITING
NCT06810427
NA

A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings

Sponsor: Carilion Clinic

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

21 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

18

Start Date

2025-01-16

Completion Date

2026-07-31

Last Updated

2026-03-18

Healthy Volunteers

Yes

Interventions

DEVICE

CervImage 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.

Locations (1)

Carilion Clinic

Roanoke, Virginia, United States