Pilot Study for Speculum Free Cervical Cancer Screening

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT04107181
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
21 Years - 65 Years
Healthy Volunteers
Accepted

Interventions

  • Introducer "calla" device — DEVICE
    The research introducer will be used after the patient consents prior to the annual pap smear.
  • Interviews only — BEHAVIORAL
    Healthy volunteer interviews

Study Details

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

Key Dates

Start date
Apr 14, 2016
Status verified
Mar 2026
Primary completion
Feb 1, 2028
Completion
Feb 1, 2028

Study Design

Enrollment
305 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Patient surveillance
    The introducer will be used during annual Pap smears for cervical cancer screening.
  • Experimental: Healthy Volunteers
    There will be 2 types of healthy volunteers recruited to participate in this arm. The home study is to determine ease of use/feasibility of the introducer. The other group of healthy volunteers will be interviewed only. The goal of this study is to better understand how to improve women's health through learning about women's perceptions of their reproductive anatomy, specifically the cervix, comfort in discussing reproductive health topics with providers, and thoughts on two tools used to see the cervix.

Primary Outcome Measure

Assessment of introducer [ Time Frame: Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke UniversityDurhamNorth Carolina27710
Nimmi Ramanujam, PhD
[email protected]
Jennifer Gallagher, BA
[email protected]
9199701551

Find similar trials in Durham, NC

By condition
Cervical cancer
By specialty
OncologyGynecologic oncologyWomen's health
By research site
Duke University· Durham, NC

Related Studies