Pilot Study for Speculum Free Cervical Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Introducer "calla" device, Interviews only.
- Who it may be relevant to
- Registry conditions: Cervical Cancer. Basic parameters: 21 years — 65 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
Overview
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.
Interventions
- Device Introducer "calla" device
The research introducer will be used after the patient consents prior to the annual pap smear. - Behavioral Interviews only
Healthy volunteer interviews
Primary outcome measures
- Assessment of introducer [Time frame: Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Screening
Study locations
United States · 1 center
- Duke University — Durham
Identifiers
NCT: NCT04107181 · Pro00008173_1 · R01CA239268-04