Trial Outcomes & Findings for Cervix Monitor for Elasticity and Length Measurements (NCT NCT03199079)
NCT ID: NCT03199079
Last Updated: 2022-10-17
Results Overview
Young's modulus of the cervix at 4 locations. Units of measurement is kPa.
Recruitment status
COMPLETED
Target enrollment
20 participants
Primary outcome timeframe
During examination procedure
Results posted on
2022-10-17
Participant Flow
Participant milestones
| Measure |
Non-pregnant Women
Adult women age 21-44 years; 10 non-pregnant women
|
Pregnant Women
Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
|
|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cervix Monitor for Elasticity and Length Measurements
Baseline characteristics by cohort
| Measure |
Group 1: Non-pregnant Women
n=10 Participants
Non-pregnant women with normal pelvic floor
Cervix Monitor: Cervix elasticity and length measurements by Cervix Monitor
|
Group 2: Pregnant Women
n=10 Participants
Pregnant women; 22-29 weeks of pregnancy
Cervix Monitor: Cervix elasticity and length measurements by Cervix Monitor
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.9 years
STANDARD_DEVIATION 7.1 • n=5 Participants
|
32.4 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
34.2 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
11 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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During examination procedureYoung's modulus of the cervix at 4 locations. Units of measurement is kPa.
Outcome measures
| Measure |
Non-pregnant Women
n=10 Participants
Adult women age 21-44 years; 10 non-pregnant women
|
Pregnant Women
n=10 Participants
Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
|
|---|---|---|
|
Cervix Elasticity
|
54 kPa
Standard Deviation 17
|
19.7 kPa
Standard Deviation 15.4
|
SECONDARY outcome
Timeframe: During examination procedureCervix length in mm
Outcome measures
| Measure |
Non-pregnant Women
n=10 Participants
Adult women age 21-44 years; 10 non-pregnant women
|
Pregnant Women
n=10 Participants
Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
|
|---|---|---|
|
Cervix Length
|
42 mm
Standard Deviation 13
|
30.7 mm
Standard Deviation 6.6
|
Adverse Events
Non-pregnant Women
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Pregnant Women
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
Egorov Vladimir, Principal Investigator
Advanced Tactile Imaging, Inc.
Phone: 609 883-0100
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place