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

Last updated: May 22, 2025
Sponsor: Carilion Clinic
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cervical Intraepithelial Neoplasia

Neoplasms

Treatment

CervImage device

Clinical Study ID

NCT06810427
IRB-24-2185
2R44CA254586-02
  • Ages 21-70
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient 21 to 70 years of age at screening

  • Patients with known HPV infection or cervical intraepithelial neoplasia (16patients)

  • Healthy patients without history of HPV/CIN (2 patients)

  • Participants able to consent for themselves

Exclusion

Exclusion Criteria:

  • Cognitive Impairment

  • Currently Pregnant

  • Incarcerated Individual

  • Any condition which in the clinical judgement of the PI makes the subject unsuitableor unsafe for study enrollment

Study Design

Total Participants: 18
Treatment Group(s): 1
Primary Treatment: CervImage device
Phase:
Study Start date:
January 16, 2025
Estimated Completion Date:
July 16, 2025

Study 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.

Connect with a study center

  • Carilion Clinic

    Roanoke, Virginia 24013
    United States

    Site Not Available

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