Cervical CancerCallaNCT04107181
Pilot Study for Speculum Free Cervical Cancer Screening
A study testing Introducer "calla" device and Interviews only in people with Cervical Cancer, run by Duke University at 1 site in United States.
Trial summary
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies. Read more about this study
- Who is it for?
- Ages 21 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Cancer
- What is being tested?
- Introducer "calla" device and Interviews only
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 305 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2016to 1 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy female
- Aged 21-65 years
- Have had a pelvic exam
- Have conversational proficiency in English
- Highest level of education attained
Who cannot join
- Pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke University
Durham, North Carolina, 27710
Nimmi Ramanujam, PhD, nimmi@duke.edu
Jennifer Gallagher, BA, 9199701551, jennifer.gallagher@duke.edu
About this study
Official title: A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
The objective of the work described in this protocol is to determine the optical signatures of cervical dysplasia using optical technologies.
Read the 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.
- Conditions
- Cervical Cancer
- Being tested
- Introducer "calla" device, Interviews only
- Keywords
- Pap smear
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introducer "calla" deviceDevice
The research introducer will be used after the patient consents prior to the annual pap smear.
Interviews onlyBehavioural
Healthy volunteer interviews
| Study group | Role | What they receive |
|---|---|---|
| Patient surveillance | Experimental | The introducer will be used during annual Pap smears for cervical cancer screening. Receives: Device: Introducer "calla" device |
| Healthy Volunteers | Experimental | 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. Receives: Behavioral: Interviews only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of introducer
We will conduct interviews/surveys to determine if subjects enrolled prefer introducer over SOC speculum
Measured: Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start14 Apr 2016
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 305 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Korle-Bu Teaching Hospital, Accra, Ghana, National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Nimmi Ramanujam, PhD, Principal investigator, Duke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107181
- Sponsor's protocol ID
- Pro00008173_1
- Other IDs
- R01CA239268-04
- Acronym
- Calla
- Status last verified
- Mar 2026
- First submitted
- 11 Sep 2019
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Continuation to Assess the Use of an Introducer "Calla" During Cervical Cancer Screening
- ClinicalTrials.gov ID
- NCT04107181
- Acronym / sponsor ID
- Calla / Pro00008173_1
- Conditions
- Cervical Cancer
- Keywords
- Pap smear
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 305 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Korle-Bu Teaching Hospital, Accra, Ghana, National Cancer Institute (NCI)
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 27 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient surveillance | Experimental | Device: Introducer "calla" deviceThe introducer will be used during annual Pap smears for cervical cancer screening. |
| Healthy Volunteers | Experimental | Behavioral: Interviews onlyThere 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. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy female
- Aged 21-65 years
- Have had a pelvic exam
- Have conversational proficiency in English
- Highest level of education attained
Key exclusion criteria (1 listed)
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Introducer "calla" deviceThe research introducer will be used after the patient consents prior to the annual pap smear. | Device | Patient surveillance |
| Interviews onlyHealthy volunteer interviews | Behavioural | Healthy Volunteers |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nimmi Ramanujam, PhD principal investigator
Duke
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introducer "calla" device and Interviews only in people with Cervical Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nimmi Ramanujam, PhD (9196605307, nimmi@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of introducer (time frame: Up to 1 week (at time of pap smear for patients and up to 1 week for healthy volunteers)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.