Cervix Monitor for Elasticity and Length Measurements

• Sponsor: Advanced Tactile Imaging, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03199079
• Collaborator: Princeton Urogynecology (Other), Rutgers, The State University of New Jersey (Other)
• Enrollment: 20
• Locations: 2
• Actual Duration (Months): 9.5
• Patients Per Site: 10
• Patients Per Site Per Month: 1.1

Study Details

Study Description

Brief Summary

Preterm birth is a leading global cause of neonatal mortality despite of numerous advances and intensive research in perinatal medicine. Almost one million children die each year due to complications of preterm birth and in almost all countries with reliable data, preterm birth rates are increasing. Of the 14 million survivors per year, many face a lifetime of disability, including learning disabilities, visual and hearing impairments. Spontaneous preterm delivery (SPTD) is often multi factorial event, precocious cervical softening, shortening and dilatation are a common denominator. The majority of preterm births happen spontaneously, though some are due to early induction of labor or cesarean birth, typically due to medical maternal of neonatal conditions.

Condition or Disease	Intervention/Treatment	Phase
Preterm Birth	Other: Measurement

Detailed Description

The uterine cervix has to provide structural integrity and mechanical resistance to ensure normal development of the fetus as the uterus expands to accommodate the fetus growth. Preterm delivery is closely related to a premature cervical ripening. The scientific bases for the proposed project is the elasticity modulus of a cervix is a more sensitive parameter characterizing the stage of cervical ripening. The main component of the cervix tissue is a collagen. Cervical ripening is the result of realignment of collagen, degradation of collagen cross-linking due to proteolytic enzymes. These processes affect the elasticity modulus of the cervical tissue. Therefore, assessment of cervix by a device measuring cervical elasticity and cervical length appears to be and adequate approach for identifying pregnant women at high risk of spontaneous preterm delivery. The primary cervical elasticity assessment currently used in clinical practice is relying on the evaluation of the cervix as "hard, medium or soft". In the scope of this project the investigators propose to develop and clinically validate a new and cost-effective device, Cervix Monitor for detecting cervix conditions leading to SPTD and its risk assessment. The CM will be based on measuring of the applied pressure to the cervix by a tactile sensor array and ultrasound measurement of cervix length .

Study Design

• Study Type: Observational
• Actual Enrollment: 20 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Cervix Monitor for Risk Assessment of Spontaneous Preterm Delivery
• Actual Study Start Date: May 1, 2017
• Actual Primary Completion Date: Jan 5, 2018
• Actual Study Completion Date: Feb 14, 2018

Arms and Interventions

Arm	Intervention/Treatment
Group 1: Non-pregnant women Non-pregnant women with normal pelvic floor	Other: Measurement; Measurement of cervix elasticity and length measurements is not an intervention
Group 2: Pregnant women Pregnant women; 22-29 weeks of pregnancy	Other: Measurement; Measurement of cervix elasticity and length measurements is not an intervention

Outcome Measures

Primary Outcome Measures

1. Cervix Elasticity [During examination procedure]

   Young's modulus of the cervix at 4 locations. Units of measurement is kPa.

Secondary Outcome Measures

1. Cervix Length [During examination procedure]

   Cervix length in mm

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years to 44 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

1. Adult women age 21-44 years

2. Non-pregnant women, or

3. Pregnant women

Exclusion Criteria:

1. Active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder

2. Ongoing or prior radiation therapy for abdominal or pelvic cancer

3. Recent (less than four months) pelvic surgery

4. Surgically absent uterus, rectum or bladder

5. Significant circulatory or cardiac conditions that could cause excessive risk from the examination as determined by attending physician

6. Severe abdominal or pelvic adhesions preventing access to pertinent anatomy

7. Known or suspected bleeding disorder

8. HIV or hepatitis B positive serology

9. Warty lesions on the vulva

10. Extensive varicose veins on the vulva

11. Active skin infection or ulceration within the vagina/vulva (Herpes infection)

12. Presence of a vaginal septum

13. Severe hemorrhoids

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers Robert Wood Johnson Medical School	New Brunswick	New Jersey	United States	08854
2	Princeton Urogynecology	Princeton	New Jersey	United States	08540

Sponsors and Collaborators

• Advanced Tactile Imaging, Inc.
• Princeton Urogynecology
• Rutgers, The State University of New Jersey

Investigators

• Principal Investigator: Vladimir Egorov, PhD, Advanced Tactile Imaging, Inc.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 5, 2016

More Information

Publications

None provided.

• Responsible Party: Advanced Tactile Imaging, Inc.
• ClinicalTrials.gov Identifier: NCT03199079
• Other Study ID Numbers: CM01A/B
• First Posted: Jun 26, 2017
• Last Update Posted: Apr 14, 2020
• Last Verified: Apr 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Premature Birth

Study Results

Participant Flow

Arm/Group Title	Non-pregnant Women	Pregnant Women
Arm/Group Description	Adult women age 21-44 years; 10 non-pregnant women	Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
Period Title: Overall Study
STARTED	10	10
COMPLETED	10	10
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Group 1: Non-pregnant Women	Group 2: Pregnant Women	Total
Arm/Group Description	Non-pregnant women with normal pelvic floor Cervix Monitor: Cervix elasticity and length measurements by Cervix Monitor	Pregnant women; 22-29 weeks of pregnancy Cervix Monitor: Cervix elasticity and length measurements by Cervix Monitor	Total of all reporting groups
Overall Participants	10	10	20
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	10 100%	10 100%	20 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	35.9 (7.1)	32.4 (5.6)	34.2 (6.5)
Sex: Female, Male (Count of Participants)
Female	10 100%	10 100%	20 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 10%	0 0%	1 5%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	1 10%	7 70%	8 40%
White	8 80%	3 30%	11 55%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	10 100%	10 100%	20 100%

Outcome Measures

1. Primary Outcome

Title	Cervix Elasticity
Description	Young's modulus of the cervix at 4 locations. Units of measurement is kPa.
Time Frame	During examination procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-pregnant Women	Pregnant Women
Arm/Group Description	Adult women age 21-44 years; 10 non-pregnant women	Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
Measure Participants	10	10
Mean (Standard Deviation) [kPa]	54 (17)	19.7 (15.4)

2. Secondary Outcome

Title	Cervix Length
Description	Cervix length in mm
Time Frame	During examination procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Non-pregnant Women	Pregnant Women
Arm/Group Description	Adult women age 21-44 years; 10 non-pregnant women	Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
Measure Participants	10	10
Mean (Standard Deviation) [mm]	42 (13)	30.7 (6.6)

Adverse Events

Time Frame	Nine (9) months
Adverse Event Reporting Description	Cervix monitor device is a low risk device. All-Cause Mortality was not monitored/assessed.
Arm/Group Title	Non-pregnant Women		Pregnant Women
Arm/Group Description	Adult women age 21-44 years; 10 non-pregnant women		Adult woman age 21-44 years; 22-29 weeks of pregnancy; 10 women
All Cause Mortality
	Non-pregnant Women		Pregnant Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Non-pregnant Women		Pregnant Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)
Other (Not Including Serious) Adverse Events
	Non-pregnant Women		Pregnant Women
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/10 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.