Pilot Study for Speculum Free Cervical Cancer Screening (Calla)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04107181|
Recruitment Status : Suspended (COVID-19)
First Posted : September 27, 2019
Last Update Posted : May 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Cervical Cancer||Device: Introducer "calla" device Behavioral: Interviews only||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||305 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening|
|Actual Study Start Date :||April 14, 2016|
|Estimated Primary Completion Date :||December 31, 2021|
|Estimated Study Completion Date :||December 31, 2021|
Experimental: Patient surveillance
The introducer will be used during annual Pap smears for cervical cancer screening.
Device: Introducer "calla" device
The research introducer will be used after the patient consents prior to the annual pap smear.
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.
Behavioral: Interviews only
Healthy volunteer interviews
- Assessment of introducer [ Time Frame: 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04107181
|United States, North Carolina|
|Durham, North Carolina, United States, 27710|
|Principal Investigator:||Nimmi Ramanujam, PhD||Duke|