Cervical EpitheliaNCT02903394
Coherence Imaging of the Cervical Epithelium
A study testing mLCI Device in people with Cervical Epithelia, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Epithelia
- What is being tested?
- mLCI Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2016to 24 Oct 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- able to provide informed consent
- willing to abstain from sexual intercourse for at least 24 hours before study visit
Who cannot join
- pregnant
- using an intrauterine device (IUD)
- have a current gynecological infection or discharge
- have had any cervical surgery
- had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
- currently enrolled in any research studies involving the application of vaginal formulations
- employed or supervised by the study investigators
- have any other condition, that, in the opinion of the study clinician, would contraindicate participation in the study
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.
- Conditions
- Cervical Epithelia
- Being tested
- mLCI Device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mLCI DeviceDevice
imaging of cervical epithelium using mLCI device
| Study group | Role | What they receive |
|---|---|---|
| mLCI imaging | Experimental | mLCI device images cervical epithelium Receives: Device: mLCI Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Interferometric Data Acquired From Cervical Epithelium
measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
Measured: day 1
Secondary outcomes (2)
Number of Patients With Automated Classification of Cervical Epithelium
The number of patients for which an interferometric tissue classification was made using optical mLCI data
Measured: day 1
Number and Frequency of Adverse Events
Number of adverse events experienced by patients during the mLCI study.
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2016 (estimated)
- Study start27 Oct 2016
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Cervical EpitheliaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Jacobi Medical Center
- Responsible party
- Sponsor
- Investigators
- Adam Wax, Ph.D., Principal investigator, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02903394
- Sponsor's protocol ID
- Pro00070555
- Other IDs
- R01CA167421
- Status last verified
- Oct 2018
- First submitted
- 1 Sep 2016
- Last updated
- 14 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coherence Imaging of the Cervical Epithelium
- ClinicalTrials.gov ID
- NCT02903394
- Acronym / sponsor ID
- Pro00070555
- Conditions
- Cervical Epithelia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Jacobi Medical Center
- Study start
- 27 Oct 2016 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 16 Sep 2016 (estimated)
- Results
- Posted 14 Nov 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a multiplexed low coherence interferometry (mLCI) endoscopic probe for mapping the epithelial types of the cervix. This vaginal mLCI probe will obtain optical measurements from the cervix. These measurements can be used to create a map of the surface cells that distinguishes ectocervical epithelia, endocervical epithelia, and the squamocolumnar junction (t-zone), which is the region where cervical dysplasia is most likely to occur.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mLCI imaging | Experimental | Device: mLCI DevicemLCI device images cervical epithelium |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- able to provide informed consent
- willing to abstain from sexual intercourse for at least 24 hours before study visit
Key exclusion criteria (8 listed)
- pregnant
- using an intrauterine device (IUD)
- have a current gynecological infection or discharge
- have had any cervical surgery
- had medical or cosmetic surgery involving the reproductive organs or genitals within the past 6 months
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 |
|---|---|---|
| mLCI Deviceimaging of cervical epithelium using mLCI device | Device | mLCI imaging |
Primary outcome
Number of Patients With Interferometric Data Acquired From Cervical Epithelium
Time frame: day 1
measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
2 secondary outcomes
Number of Patients With Automated Classification of Cervical Epithelium
Time frame: day 1
Number and Frequency of Adverse Events
Time frame: day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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. This study is not recruiting at the moment.
Adam Wax, Ph.D. principal investigator
professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mLCI Device in people with Cervical Epithelia, 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 2 inclusion and 8 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: finished, as of the sponsor's last update on 14 Nov 2018. 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?
Yes. Results are posted in the registry (first posted 14 Nov 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients With Interferometric Data Acquired From Cervical Epithelium (time frame: day 1). 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 14 Nov 2018.