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

Carilion Clinic

Status: Active, not recruiting

Conditions: Cervical Intraepithelial Neoplasia

Treatments: Device: CervImage device

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06810427

IRB-24-2185

2R44CA254586-02 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 18 patients

Sex: Female

Ages: 21 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

CervImage Device

Experimental group

Description:

CervImage device for cervical imaging to detect cervical intraepithelial dysplasia \[CIN\] via colposcopy

Treatment:

Device: CervImage device