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OviTex Mesh for Hernia Repair (BRAVOII Trial)
BRAVOII Trial Summary
This trial will study the safety and effectiveness of a new medical device for treating ventral hernias.
BRAVOII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowBRAVOII Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.BRAVOII Trial Design
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Who is running the clinical trial?
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- I am at least 22 years old or considered an adult by law.My wound healing ability is rated as mild to moderate.My upcoming surgery will be performed using a robot.I can participate fully and for the entire duration of the study.The area requiring a surgical implant is smaller than 25 x 40 cm for OviTex Core and 12 x 18 cm for OviTex LPR.I need surgery for a hernia in my abdomen or groin area, involving an implant.I am willing and have signed the consent form for this study.
- Group 1: OviTex Reinforced Tissue Matrix
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
How many individuals are undergoing this experiment?
"The sponsor, Emergent Clinical Consulting LLC, requires 160 patients that meet the inclusion criteria to effectively execute this study. The trial will be administered from several medical centres including St. Francis Hospital in Roslyn New york and Houston Methodist in Houston Texas."
What are the intended effects of this experiment?
"The principal aim of the trial, as elucidated by its sponsor Emergent Clinical Consulting LLC and to be measured in the initial 3 months after hernia repair surgery, is Early Post-operative Complications. Secondary objectives include Late Surgical Site Occurrences or Wound Related Events, Hernia Recurrence at the site of operation and Patient Reported Outcomes including Quality Of Life metrics and pain evaluations."
Is recruitment for this trial still underway?
"As evidenced by the clinicaltrials.gov records, this medical experiment is open to applicants and was initially posted on April 14th 2021. Records were last edited on September 28th 2022."
Who else is applying?
What state do they live in?
What site did they apply to?
What portion of applicants met pre-screening criteria?
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