Pilot Study for Speculum Free Cervical Cancer Screening (Calla)

Duke University

Status: Enrolling

Conditions: Cervical Cancer

Treatments: Device: Introducer "calla" device; Behavioral: Interviews only

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04107181

Pro00008173_1

R01CA239268-04 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 305 estimated patients

Sex: Female

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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305 participants in 2 patient groups

Patient surveillance

Experimental group

Description:

The introducer will be used during annual Pap smears for cervical cancer screening.

Treatment:

Device: Introducer "calla" device

Healthy Volunteers

Experimental group

Description:

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.

Treatment:

Behavioral: Interviews only