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

Running, not enrolling · Not applicable

Conditions studied: Cervical Intraepithelial Neoplasia

In brief

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 facts

Study ID

NCT06810427

Run by

Carilion Clinic

People needed

18

Starts

2025-01-16

Expected to finish

2026-07-31

Last updated by the study team

2026-03-18

Who can join

Age: 21 and older, up to 70. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Carilion Clinic — Roanoke, Virginia, United States

Full record on ClinicalTrials.gov

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