Ultrasound Assessment of Ventral Hernia Defects

NCT03043079 | Completed Results FDA Device

• 1 other identifier: 823896
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

Quantitative radiographic imaging holds promise as a novel and innovative strategy to assess ventral hernia patients. Assessing abdominal wall changes surrounding ventral hernia using shear wave velocity values measured with ultrasound will identify features of the abdominal wall that differ between healthy volunteers and subjects scheduled to have ventral hernia repair. Through the use of ultrasound including shear wave velocity measurements, the abdominal wall of 25 subjects scheduled to have ventral hernia repair will be compared to those of 35 healthy volunteers. The ultrasound measurements will elucidate if ventral hernia affects abdominal wall elasticity and effect surgical outcomes.

Conditions

Ventral Incisional Hernia

Outcome Measures

Primary Outcomes (1)

• Difference in the Shear Wave Velocity Measurements in the Abdominal Wall Between Ventral Hernia and Healthy Abdominal Wall

  Differences in the shear wave velocity measurements in the abdominal wall of healthy and ventral hernia patients

  study intiation ultrasound scan lasting up to 45 minutes

Secondary Outcomes (2)

• Difference in Shear Wave Velocity Measurement in the Abdominal Wall Pre and Post Hernia Repair

  through study completion, an up to 26 weeks postoperative

• Incidental Findings and Ultrasound Safety

  1 year

Study Arms (3)

Ventral Hernia

EXPERIMENTAL

Twenty-five patients diagnosed with ventral hernia

Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity

Healthy Volunteers

OTHER

Twenty-five volunteers without ventral hernia

Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity

Active Health Volunteers

OTHER

Ten healthy volunteers with an International Physical Activity Questionnaire (IPAQ) with the scoring result of High or Vigorous Intensity

Diagnostic Test: Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity

Interventions

Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity DIAGNOSTIC_TEST

Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)

Active Health Volunteers; Healthy Volunteers; Ventral Hernia

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• male or female between 20-70 years of age
• healthy volunteer or seeking elective ventral hernia repair

You may not qualify if:

• pregnant women

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

University of Pennsylvania Health System

Philadelphia, Pennsylvania, 19146, United States

Location

Results Point of Contact

• Title: Dr. John P Fischer
• Organization: University of Pennsylvania

john.fischer2@uphs.upenn.edu

2156627300

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assisstant Professor of Surgery

Study Record Dates

• First Submitted: January 24, 2017
• First Posted: February 3, 2017
• Study Start: April 1, 2016
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: March 24, 2020
• Results First Posted: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)