Pilot Study for Speculum Free Cervical Cancer Screening

Not Applicable

Recruiting

• Conditions: Cervical Cancer
• Interventions: Device: Introducer "calla" device; Behavioral: Interviews only

• Registration Number: NCT04107181
• Lead Sponsor: Duke University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2016-04-14
• Study First Submitted: 2019-09-11
• Study First Submitted QC: 2019-09-25
• Study First Posted: 2019-09-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-08
• Last Update Posted: 2024-01-10
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 305

Inclusion Criteria

Healthy female

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

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Exclusion Criteria

• Pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient surveillance	Introducer "calla" device	The introducer will be used during annual Pap smears for cervical cancer screening.
Healthy Volunteers	Interviews only	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 Measures

Name	Time	Method
Assessment of introducer	Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)	We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States