Speculum-Free Screening Device for Cervical Cancer (Calla Trial)

N/A

Recruiting

Led By Nimmi Ramanujam, PhD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Healthy female

Aged 21-65 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)

Awards & highlights

No Placebo-Only Group

Summary

This trial will use optical technologies to determine the optical signatures of cervical dysplasia.

Who is the study for?

This trial is for healthy women aged 21-65 who speak English well enough to have a conversation. Participants should have had a pelvic exam before and must not be pregnant. Their education level may also be considered.

What is being tested?

The study is testing a new device called 'calla' for cervical cancer screening without the need for a speculum, alongside interviews. It aims to identify specific optical patterns that indicate abnormal tissue changes.

What are the potential side effects?

Since this trial involves non-invasive interviews and the use of an introducer device, side effects are minimal but could include discomfort or anxiety during the procedure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a healthy woman.

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I am between 21 and 65 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Assessment of introducer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patient surveillanceExperimental Treatment1 Intervention

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

Group II: Healthy VolunteersExperimental Treatment1 Intervention

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.

0 / 2Eligibility criteria met