SBIR-STTR Award

Antepartum Tactile Imager for Minimizing Risk of Maternal Childbirth Trauma
Award last edited on: 3/4/2019

Sponsored Program
SBIR
Awarding Agency
NIH : NICHD
Total Award Amount
$237,959
Award Phase
1
Solicitation Topic Code
865
Principal Investigator
Vladimir Egorov

Company Information

Advanced Tactile Imaging Inc

1459 Lower Ferry Road
Trenton, NJ 08618
   (609) 333-2127
   vti@tactile-imaging.com
   www.tactile-imaging.com
Location: Single
Congr. District: 12
County: Mercer

Phase I

Contract Number: 1R43HD095223-01
Start Date: 4/3/2018    Completed: 3/31/2019
Phase I year
2018
Phase I Amount
$237,959
Over 85% of women suffer obstetric trauma to one or several components of the pelvic floor, with vagina, perineal body, levator ani muscles, and the anal sphincter complex affected most commonly. Birth injury to these integral structural components of the female pelvic floor leads to pelvic pain and dyspareunia, and serves as the most important and potentially modifiable risk factor for subsequent pelvic floor disorders. Unfortunately, there are currently no preventive strategies beyond elective Cesarean delivery, which is associated with many untoward consequences. Our central thesis that pelvic tissuesÂ’ biomechanical properties in late pregnancy determine the risk of birth injury for a set of specific intrapartum conditions, i.e. fetal head size, shape/size of maternal bony pelvis, duration of expulsive efforts. The long-term goal of this project to develop, validate and integrate into clinical practice a novel device, Antepartum Tactile Imager (ATI), to simultaneously measure biomechanical properties of various pelvic structural components that are impacted during vaginal delivery, and to develop a risk prediction model of maternal birth injury by correlating ATI data with postpartum outcomes. Ultimately, such model will enable individualized patient counseling regarding the mode of delivery and/or the need for obstetrical interventions to reduce childbirth trauma. Phase I Specific Aims target to design ATI ?-prototype and explore imaging quality, examination technique, probe design and safety in a pilot clinical study of non-pregnant and pregnant women.

Public Health Relevance Statement:
Over 85% of women suffer some degree of perineal trauma during a vaginal delivery. Cesarean delivery itself is a trauma with immediate and long term consequences. The long-term goal of this project to develop, validate and integrate into clinical practice a novel device, Antepartum Tactile Imager (ATI), to simultaneously measure biomechanical properties of various pelvic structural components that are impacted during vaginal delivery, and to develop a risk prediction model of maternal birth injury by correlating ATI data with delivery outcomes. Ultimately, such model will enable individualized patient counseling regarding the mode of delivery and/or the need for obstetrical interventions to reduce childbirth trauma.

Project Terms:
3-Dimensional; Affect; Algorithmic Software; Algorithms; Animals; antenatal; Area; Behavior; Biomechanics; Birth; Birth trauma; Certification; Cesarean section; Childbirth; Clinical; Clinical Data; clinical practice; Clinical Research; Complex; Computer Simulation; Connective Tissue; Counseling; Data; Data Reporting; Databases; design; Development; Devices; Discipline of obstetrics; Disinfection; Dyspareunia; Electromagnetics; Elements; Evaluation; Female; fetal; Genital system; Goals; Head; Human; human model; Image; imager; imaging probe; Imaging technology; improved; individual patient; Injury; Intervention; intrapartum; Knowledge; Late pregnancy; levator ani muscle; Ligaments; Location; Measures; mechanical properties; Mechanics; Modeling; modifiable risk; novel; Outcome; Pain; Patients; Pelvic Floor Disorders; Pelvic Floor Muscle; Pelvic floor structure; Pelvic Pain; Pelvis; Performance; personalized predictions; Phase; Postpartum Period; predictive modeling; Predisposition; Pregnancy; Pregnant Women; prevent; Prevention strategy; Probability; Procedures; Property; protective effect; Protocols documentation; prototype; Reporting; Reproducibility; Resolution; Risk; Risk Factors; risk minimization; Safety; Severities; Shapes; Software Design; sphincter ani muscle structure; stem; Stress; Structure; System; Tactile; Techniques; Testing; Three-Dimensional Imaging; TimeLine; Tissues; Training; Trauma; Vagina; Vaginal delivery procedure; Validation; Woman

Phase II

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Start Date: 00/00/00    Completed: 00/00/00
Phase II year
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