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

NCT06810427 | Active Not Recruiting FDA Device

• 2 other identifiers: IRB-24-21852R44CA254586-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervical Intraepithelial Neoplasia

Keywords

Cervical Lesion; Intraepithelial dysplasia; Human Papillomavirus (HPV); CervImage

Outcome Measures

Primary Outcomes (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.

  Immediately after the procedure

Secondary Outcomes (3)

• Time to Obtain Images

  Immediately after the procedure

• Comfort/Discomfort of Subject

  Immediately after the procedure

• Physician Satisfaction

  Immediately after the procedure

Study Arms (1)

CervImage Device

EXPERIMENTAL

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

Device: CervImage device

Interventions

CervImage device 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.

Also known as: CervImage

CervImage Device

Eligibility Criteria

• Age: 21 Years - 70 Years
• Gender Eligibility Details: Participant must have cervix at time of study participation
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Carilion Clinic: lead
• National Cancer Institute (NCI): collaborator
• Pensievision, Inc: collaborator

Study Sites (1)

Carilion Clinic

Roanoke, Virginia, 24013, United States

Location

Related Publications (16)

• 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.

  PMID: 33538338 BACKGROUND

• 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.

  PMID: 32782524 BACKGROUND

• 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.

  PMID: 35164716 BACKGROUND

• 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.

  PMID: 33388330 BACKGROUND

• 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.

  PMID: 35040970 BACKGROUND

• 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.

  PMID: 33317633 BACKGROUND

• 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.

  PMID: 28669152 BACKGROUND

• 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

  BACKGROUND

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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 24929434 BACKGROUND

• 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/

  PMID: 24716265 BACKGROUND

• Byun JM, Kim YN, Jeong DH, Kim KT, Sung MS, Lee KB. Three-dimensional transvaginal ultrasonography for locally advanced cervical cancer. Int J Gynecol Cancer. 2013 Oct;23(8):1459-64. doi: 10.1097/IGC.0b013e3182a16997.

  PMID: 24257560 BACKGROUND

Related Links

• Pensievision, Inc - CervImage

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Isaiah Johnson, MD

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 5, 2025
• Study Start: January 16, 2025
• Primary Completion: May 16, 2025
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)