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Reinforced Tissue Matrix

OviTex Mesh for Hernia Repair (BRAVOII Trial)

N/A
Recruiting
Led By Geoffrey Slayden, MD
Research Sponsored by Tela Bio Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject is at least 22 years old, (or considered an adult per state law)
Subject has VHWG score of Grade 1, 2 or 3
Timeline
Screening 3 weeks
Treatment Varies
Follow Up occurring > 3 months after index surgery.
Awards & highlights

BRAVOII Trial Summary

This trial will study the safety and effectiveness of a new medical device for treating ventral hernias.

Who is the study for?
This trial is for adults at least 22 years old with a ventral or inguinal hernia that's small enough to be repaired robotically using OviTex mesh. Participants must have a clean to contaminated wound, be able to fill out questionnaires about their quality of life and pain, and commit to the full duration of the study.Check my eligibility
What is being tested?
The study is testing how well OviTex mesh works in repairing ventral or inguinal hernias when used in robotic surgery. It aims to track post-operative complications and chances of the hernia coming back, involving up to 160 subjects across multiple sites.See study design
What are the potential side effects?
While specific side effects are not listed here, common risks associated with surgical mesh may include pain, infection, bleeding, hernia recurrence, adhesion formation (where tissue sticks together), and possible reaction to the material.

BRAVOII Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am at least 22 years old or considered an adult by law.
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My wound healing ability is rated as mild to moderate.
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My upcoming surgery will be performed using a robot.
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I can participate fully and for the entire duration of the study.
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I need surgery for a hernia in my abdomen or groin area, involving an implant.
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I am willing and have signed the consent form for this study.

BRAVOII Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~occurring > 3 months after index surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and occurring > 3 months after index surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Early post-operative complications
Early surgical site occurrences or wound related events
Secondary outcome measures
Hernia Recurrence
Late post-operative complications
Late surgical site occurrences or wound related events
+1 more

BRAVOII Trial Design

1Treatment groups
Experimental Treatment
Group I: OviTex Reinforced Tissue MatrixExperimental Treatment1 Intervention
This is a single-arm study. All study subjects will receive OviTex.

Find a Location

Who is running the clinical trial?

Emergent Clinical Consulting, LLCIndustry Sponsor
3 Previous Clinical Trials
2,439 Total Patients Enrolled
Tela Bio IncLead Sponsor
2 Previous Clinical Trials
292 Total Patients Enrolled
MCRAIndustry Sponsor
29 Previous Clinical Trials
8,996 Total Patients Enrolled

Media Library

OviTex Reinforced Tissue Matrix (Reinforced Tissue Matrix) Clinical Trial Eligibility Overview. Trial Name: NCT04779918 — N/A
Inguinal Hernia Research Study Groups: OviTex Reinforced Tissue Matrix
Inguinal Hernia Clinical Trial 2023: OviTex Reinforced Tissue Matrix Highlights & Side Effects. Trial Name: NCT04779918 — N/A
OviTex Reinforced Tissue Matrix (Reinforced Tissue Matrix) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04779918 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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."

Answered by AI

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."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
GenesisCare
Houston Methodist
What portion of applicants met pre-screening criteria?
Did not meet criteria
~29 spots leftby Dec 2024