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

March 16, 2026 updated by: Carilion Clinic
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Virginia
      • Roanoke, Virginia, United States, 24013
        • Carilion Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CervImage Device
CervImage device for cervical imaging to detect cervical intraepithelial dysplasia [CIN] via colposcopy
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.

Other Names:
  • CervImage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Quality and Resolution vs Standard-of-Care
Time Frame: Immediately after the procedure
CervImage images evaluated on Spatial resolution, distortion, brightness, magnification, color correctness, corrupted pixel rows, and visual inspection vs standard-of-care cervical imaging for intraepithelial dysplasia [CIN] visualization.
Immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Obtain Images
Time Frame: Immediately after the procedure
Time required by the physician to obtain cervical images needed with the CervImage device vs standard-of-care device.
Immediately after the procedure
Comfort/Discomfort of Subject
Time Frame: Immediately after the procedure
Subjective assessment of discomfort [and comfort] with using the CervImage device vs standard-of-care device for colposcopy, by the subject through use of a quantitative questionnaire with a scale of 1 to 10 with 1 being no pain and 10 being extremely painful.
Immediately after the procedure
Physician Satisfaction
Time Frame: Immediately after the procedure
Overall satisfaction with use of the CervImage device vs standard-of-care device by physician using a quantitative questionnaire with a scale of 1 to 10 with 1 being dissatisfied and 10 being completely satisfied.
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carilion Clinic

Collaborators

National Cancer Institute (NCI)
Pensievision, Inc

Investigators

  • Principal Investigator: Isaiah Johnson, MD, Carilion Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 16, 2025

Primary Completion (Actual)

May 16, 2025

Study Completion (Estimated)

July 31, 2026

Study Registration Dates

First Submitted

January 25, 2025

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

February 5, 2025

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 16, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB-24-2185
  • 2R44CA254586-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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