Active — Not RecruitingNot Applicable

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

United States18 participantsStarted 2025-01-16

Plain-language 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.

Who can participate

Age range21 Years – 70 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Image Quality and Resolution vs Standard-of-Care

Timeframe: Immediately after the procedure

Trial details

NCT IDNCT06810427

SponsorCarilion Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-16

View on ClinicalTrials.gov More Cervical Intraepithelial Neoplasia trials