A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings
NCT ID: NCT06810427
Last Updated: 2025-05-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
18 participants
INTERVENTIONAL
2025-01-16
2025-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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CervImage Device
CervImage device for cervical imaging to detect cervical intraepithelial dysplasia \[CIN\] via colposcopy
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.
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Currently Pregnant
* Incarcerated Individual
* Any condition which in the clinical judgement of the PI makes the subject unsuitable or unsafe for study enrollment
21 Years
70 Years
FEMALE
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Pensievision, Inc
UNKNOWN
Carilion Clinic
OTHER
Responsible Party
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Principal Investigators
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Isaiah Johnson, MD
Role: PRINCIPAL_INVESTIGATOR
Carilion Clinic
Locations
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Carilion Clinic
Roanoke, Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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/
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.
Provided Documents
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Document Type: Informed Consent Form
Related Links
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Pensievision, Inc - CervImage
Other Identifiers
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IRB-24-2185
Identifier Type: -
Identifier Source: org_study_id
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