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Optical Technology

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

Calla Trial 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.Check my eligibility
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.See study design
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.

Calla Trial 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.
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I have had a pelvic exam.

Calla Trial 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)
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Assessment of introducer

Calla 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.

Find a Location

Who is running the clinical trial?

Korle-Bu Teaching Hospital, Accra, GhanaOTHER
10 Previous Clinical Trials
8,896 Total Patients Enrolled
Duke UniversityLead Sponsor
2,356 Previous Clinical Trials
3,418,796 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,627 Previous Clinical Trials
40,927,036 Total Patients Enrolled

Media Library

Introducer 'calla' device (Optical Technology) Clinical Trial Eligibility Overview. Trial Name: NCT04107181 — N/A
Cervical Cancer Research Study Groups: Healthy Volunteers, Patient surveillance
Cervical Cancer Clinical Trial 2023: Introducer 'calla' device Highlights & Side Effects. Trial Name: NCT04107181 — N/A
Introducer 'calla' device (Optical Technology) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04107181 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research opportunity remain accessible to participants?

"Indeed, the evidence on clinicaltrials.gov suggests that this medical experiment is actively seeking participants. It was initially posted April 14th 2016 and recently revised June 24th 2022; 305 individuals are required to be recruited from 1 site."

Answered by AI

May individuals below the age of fifty participate in this research?

"This research requires the enrolment of patients who are within 21 to 65 years old."

Answered by AI

Who has the necessary qualifications to participate in this investigation?

"To qualify for the study, potential participants should have uterine cervical neoplasms and lie within the designated age range of 21-65. A total of 305 candidates are expected to be enrolled in this trial."

Answered by AI

How many individuals are involved in this research endeavor?

"Affirmative. Clinicaltrials.gov has the relevant information, which shows that this medical trial was initially posted on April 14th 2016 and last edited on June 24th 2022. This initiative is currently seeking 305 patients from a single location."

Answered by AI
~29 spots leftby Feb 2025