Trial Outcomes & Findings for Coherence Imaging of the Cervical Epithelium (NCT NCT02903394)
NCT ID: NCT02903394
Last Updated: 2018-11-14
Results Overview
measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
day 1
Results posted on
2018-11-14
Participant Flow
Participant milestones
| Measure |
mLCI Imaging (Pilot)
Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
|
mLCI Imaging (Jacobi)
Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.
|
|---|---|---|
|
Overall Study
STARTED
|
5
|
50
|
|
Overall Study
COMPLETED
|
5
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Coherence Imaging of the Cervical Epithelium
Baseline characteristics by cohort
| Measure |
mLCI Imaging (Pilot)
n=5 Participants
Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
|
mLCI Imaging (Jacobi)
n=50 Participants
Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
29.8 years
n=5 Participants
|
29.4 years
n=7 Participants
|
29.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
5 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: day 1measured by: ability to receive interferometric data from at least one portion of the cervical epithelium
Outcome measures
| Measure |
mLCI Imaging (Pilot)
n=5 Participants
Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
|
mLCI Imaging (Jacobi)
n=50 Participants
Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.
|
|---|---|---|
|
Number of Patients With Interferometric Data Acquired From Cervical Epithelium
|
3 patients
|
41 patients
|
SECONDARY outcome
Timeframe: day 1Population: Patients from whom epithelial interferometric data were successfully captured and for whom a corresponding colposcope image could be registered. No pilot study patients were included as no colposcopic examination was conducted in the pilot phase.
The number of patients for which an interferometric tissue classification was made using optical mLCI data
Outcome measures
| Measure |
mLCI Imaging (Pilot)
Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
|
mLCI Imaging (Jacobi)
n=41 Participants
Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.
|
|---|---|---|
|
Number of Patients With Automated Classification of Cervical Epithelium
|
—
|
36 patients
|
SECONDARY outcome
Timeframe: day 1Number of adverse events experienced by patients during the mLCI study.
Outcome measures
| Measure |
mLCI Imaging (Pilot)
n=5 Participants
Pilot study. 5 women from ages 24 to 34 recruited at Duke University (Durham, NC). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
|
mLCI Imaging (Jacobi)
n=50 Participants
Primary arm of present study. 50 women from ages 18 to 42 recruited from routine care population at New York City Health + Hospitals / Jacobi (Bronx, New York, NY). Exclusion criteria included history of cervical dysplasia or previous surgery on the cervix, complaint of vaginal discharge or suspicion of sexually transmitted infection at the time of presentation, or positive urine pregnancy test.
Women were examined by speculum to visualize the cervix. Wallach colposcope was used to acquire a photograph of the cervix. mLCI probe was then inserted through speculum and placed against the cervix by endoscopic visual guidance provided through the probe. Optical interferometric data was acquired within a 20 mm field of view, and results were analyzed to determine tissue type.
|
|---|---|---|
|
Number and Frequency of Adverse Events
|
0 events
|
0 events
|
Adverse Events
mLCI Imaging (Pilot)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
mLCI Imaging (Jacobi)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place