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Control Group 2 for Ventral Hernia (ELASTOGRAPHY Trial)
N/A
Waitlist Available
Led By Wes Love, MD
Research Sponsored by Prisma Health-Upstate
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study participation ends after surgery
Awards & highlights
ELASTOGRAPHY Trial Summary
"This trial will study patients with midline ventral incisional hernia undergoing open retromuscular VHR. They will be divided into study groups based on hernia morphology and factors affecting fasc
Who is the study for?
This trial is for patients with midline ventral incisional hernias who are scheduled for open retromuscular ventral hernia repair (VHR). It includes a variety of hernia shapes and sizes. Healthy volunteers without hernias and those having primary laparotomy will serve as controls to establish baseline measurements.Check my eligibility
What is being tested?
The study is testing the use of Shear-Wave Elastography (SWE), a type of ultrasound imaging, to measure tissue stiffness in patients undergoing surgery for incisional hernias. The goal is to understand how different factors affect the ability to close the fascial defect during VHR.See study design
What are the potential side effects?
Since this trial involves non-invasive imaging techniques like ultrasound, side effects are minimal. However, there may be some discomfort or minor risks associated with tensiometry and elective midline laparotomy used in the study.
ELASTOGRAPHY Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ study participation ends after surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study participation ends after surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Correlate Elastography measurements with MFR (Specific Aim 2)
Correlate SWE Assessment to Tensiometer (Specific Aim 3)
Determine Elasticity of Abdominal Wall Muscles (Specific Aim 1)
ELASTOGRAPHY Trial Design
2Treatment groups
Experimental Treatment
Group I: Control Group 2Experimental Treatment3 Interventions
Control group 2 patients will have no hernia and will be undergoing elective midline laparotomy.
Imaging:
Ultrasound procedure will involve the following steps:
1. For control group 1 and group 2 patients, Images will be taken at two points .
Hernia repair:
All study patients will have an open retromuscular repair with/without additional lateral
Tensiometry For all study patients, an analog spring-tensiometer will be used to assess intraoperative tension required to bring the fascia to the midline for closure.
Group II: Control Group 1Experimental Treatment1 Intervention
Control group 1 patients will have no incisional hernia or prior laparotomy.
Imaging:
Ultrasound procedure will involve the following steps:
1. For control group 1 and group 2 patients, Images will be taken at two points
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Who is running the clinical trial?
Prisma Health-UpstateLead Sponsor
82 Previous Clinical Trials
42,868 Total Patients Enrolled
Wes Love, MDPrincipal InvestigatorPrisma Health
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are potential participants still able to apply for enrollment in this ongoing research study?
"As per clinicaltrials.gov, recruitment for this particular medical investigation is currently closed. The trial was initially listed on 3rd January 2024 and last updated on 5th March 2024. Despite the closure of this study, there are presently 158 alternative studies actively seeking participants."
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