Clinical trial NCT06810427: A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings
Official title: A Novel, Low-Cost, Handheld 3D Imaging System for Improved Screening for Cervical Neoplasia in Resource-Limited Settings
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cervical Intraepithelial Neoplasia
Keywords: Cervical Lesion
Intraepithelial dysplasia
Human Papillomavirus (HPV)
CervImage
Lead sponsor: Carilion Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Pensievision, Inc
First posted: 2025-02-05
Enrollment: 18
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DEVICE_FEASIBILITY

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Image Quality and Resolution vs Standard-of-Care
timeFrame: Immediately after the procedure
Secondary outcomes:
measure: Time to Obtain Images
timeFrame: Immediately after the procedure
measure: Comfort/Discomfort of Subject
timeFrame: Immediately after the procedure
measure: Physician Satisfaction
timeFrame: Immediately after the procedure
Other outcomes:
Locations:
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Carilion Clinic
name: Isaiah Johnson, MD
role: PRINCIPAL_INVESTIGATOR
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