AzTrials
AzTrials

Cervical Intraepithelial NeoplasiaCervImageNCT06810427

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

A study testing CervImage device in people with Cervical Intraepithelial Neoplasia, run by Carilion Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 21 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Cervical Intraepithelial Neoplasia
What is being tested?
CervImage device
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
16 Jan 2025to 31 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

United States1 site

  • Carilion Clinic

    Roanoke, Virginia, 24013

Other trials in United States

About this study

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.

Read the 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.

Being tested
CervImage device
Keywords
Cervical Lesion, Intraepithelial dysplasia, Human Papillomavirus (HPV), CervImage
Medical subject headings
Uterine Cervical Dysplasia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CervImage deviceDevice

    Also called CervImage

    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.

Study groups in NCT06810427
Study groupRoleWhat they receive
CervImage DeviceExperimentalCervImage device for cervical imaging to detect cervical intraepithelial dysplasia [CIN] via colposcopy
Receives: Device: CervImage device

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Image Quality and Resolution vs Standard-of-Care

    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.

    Measured: Immediately after the procedure

Secondary outcomes (3)

  1. Time to Obtain Images

    Time required by the physician to obtain cervical images needed with the CervImage device vs standard-of-care device.

    Measured: Immediately after the procedure

  2. Comfort/Discomfort of Subject

    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.

    Measured: Immediately after the procedure

  3. Physician Satisfaction

    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.

    Measured: Immediately after the procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start16 Jan 2025
  3. Primary completion16 May 2025
  4. Study completion31 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Model description
Single-center, pilot study of the CervImage \[Pensievision, San Diego, CA\] device utilizing an (1) human papillomavirus (HPV) or Intraepithelial dysplasia (CIN) group and (2) no-HPV/CIN group with a single study intervention \[CervImage device\] for collection of quantitative data regarding imaging quality over the standard-of-care imaging modality and qualitative feedback from physician and subject.
Masking
None (open label)
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06810427
Sponsor's protocol ID
IRB-24-2185
Other IDs
2R44CA254586-02
Acronym
CervImage
Status last verified
Mar 2026
First submitted
25 Jan 2025
Last updated
18 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PubMed 33538338

  • Hull R, Mbele M, Makhafola T, Hicks C, Wang SM, Reis RM, Mehrotra R, Mkhize-Kwitshana Z, Kibiki G, Bates DO, Dlamini Z. Cervical cancer in low and middle-income countries. Oncol Lett. 2020 Sep;20(3):2058-2074. doi: 10.3892/ol.2020.11754. Epub 2020 Jun 19.

    PubMed 32782524

  • Gerstl S, Lee L, Nesbitt RC, Mambula C, Sugianto H, Phiri T, Kachingwe J, Llosa AE. Cervical cancer screening coverage and its related knowledge in southern Malawi. BMC Public Health. 2022 Feb 14;22(1):295. doi: 10.1186/s12889-022-12547-9.

    PubMed 35164716

  • Fuzzell LN, Perkins RB, Christy SM, Lake PW, Vadaparampil ST. Cervical cancer screening in the United States: Challenges and potential solutions for underscreened groups. Prev Med. 2021 Mar;144:106400. doi: 10.1016/j.ypmed.2020.106400. Epub 2021 Jan 1.

    PubMed 33388330

  • Suk R, Hong YR, Rajan SS, Xie Z, Zhu Y, Spencer JC. Assessment of US Preventive Services Task Force Guideline-Concordant Cervical Cancer Screening Rates and Reasons for Underscreening by Age, Race and Ethnicity, Sexual Orientation, Rurality, and Insurance, 2005 to 2019. JAMA Netw Open. 2022 Jan 4;5(1):e2143582. doi: 10.1001/jamanetworkopen.2021.43582.

    PubMed 35040970

  • Moucheraud C, Kawale P, Kafwafwa S, Bastani R, Hoffman RM. Health care workers' experiences with implementation of "screen and treat" for cervical cancer prevention in Malawi: A qualitative study. Implement Sci Commun. 2020 Dec 14;1(1):112. doi: 10.1186/s43058-020-00097-3.

    PubMed 33317633

  • Gupta R, Gupta S, Mehrotra R, Sodhani P. Cervical Cancer Screening in Resource-Constrained Countries: Current Status and Future Directions. Asian Pac J Cancer Prev. 2017 Jun 25;18(6):1461-1467. doi: 10.22034/APJCP.2017.18.6.1461.

    PubMed 28669152

  • Carson, J. C., Eikenberry, S. S., Smith, J. J. & Cordes, J. M. The Cornell High-Order Adaptive Optics Survey for Brown Dwarfs in Stellar Systems. II. Results from Monte Carlo Population Analyses. The Astronomical Journal 132, 1146 (2006). https://doi.org:10.1086/505705

  • Carson, J. C. et al. A DISTANCE-LIMITED IMAGING SURVEY OF SUBSTELLAR COMPANIONS TO SOLAR NEIGHBORHOOD STARS. The Astronomical Journal 137, 218 (2009).

  • Durkan, S., Janson, M. & Carson, J. C. HIGH CONTRAST IMAGING WITH SPITZER: CONSTRAINING THE FREQUENCY OF GIANT PLANETS OUT TO 1000 au SEPARATIONS. The Astrophysical Journal 824, 58 (2016). https://doi.org:10.3847/0004-637X/824/1/58

  • Carson, J. C. et al. A SPITZER IRAC IMAGING SURVEY FOR T DWARF COMPANIONS AROUND M, L, AND T DWARFS: OBSERVATIONS, RESULTS, AND MONTE CARLO POPULATION ANALYSES. The Astrophysical Journal 743, 141 (2011). https://doi.org:10.1088/0004-637X/743/2/141

  • Carson, J. et al. DIRECT IMAGING DISCOVERY OF A "SUPER-JUPITER" AROUND THE LATE BTYPE STAR κ And*. The Astrophysical Journal Letters 763, L32 (2013). https://doi.org:10.1088/2041- 8205/763/2/L32

  • Carson, B., Carson, J., Esener, S. & Liu, K. U.S. Provisional Patent: Method, System, Software and Device for Remote, Miniaturized, and Three- Dimensional Imaging and Analysis of Human Lesions; Research and Clinical Applications. (2019).

  • Baghdadchi S, Liu K, Knapp J, Prager G, Graves S, Akrami K, Manuel R, Bastos R, Reid E, Carson D, Esener S, Carson J, Liu YT. An innovative system for 3D clinical photography in the resource-limited settings. J Transl Med. 2014 Jun 15;12:169. doi: 10.1186/1479-5876-12-169.

    PubMed 24929434

  • WHO Guidelines for Screening and Treatment of Precancerous Lesions for Cervical Cancer Prevention. Geneva: World Health Organization; 2013. Available from http://www.ncbi.nlm.nih.gov/books/NBK195239/

    PubMed 24716265

Questions about this trial

What is this clinical trial studying?

A study testing CervImage device in people with Cervical Intraepithelial Neoplasia, run by Carilion Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Image Quality and Resolution vs Standard-of-Care (time frame: Immediately after the procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06810427, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in