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Pilot Study for Speculum Free Cervical Cancer Screening

Pilot Study for Speculum Free Cervical Cancer Screening

Recruiting
21-65 years
Female
Phase N/A
  • Technical (Original)
  • Simplified (AI rewritten)

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Overview

The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.

Description

This project is to assess if the introducer, "calla", can be used in place of a speculum during a routine Pap smear. For the patient arm, the introducer will be used in conjunction with standard of care procedures. The healthy volunteer arm will include taking the introducer home for a week to determine if each person can find their cervix without the help of a physician. As well as completing surveys on ease of use and demographics related to their medial history.

Eligibility

Inclusion Criteria:

Healthy female

  • Aged 21-65 years
  • Have had a pelvic exam
  • Have conversational proficiency in English
  • Highest level of education attained

Exclusion Criteria:

  • Pregnant women

Study details
    Cervical Cancer

NCT04107181

Duke University

30 March 2025

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