NCT04779918 · Tela Bio Inc
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
(BRAVOII)
What this study is about
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.
View original scientific description
This study is designed to evaluate the post-operative complications and hernia recurrence following the use of OviTex in subjects with ventral or inguinal hernias. Up to 160 subjects will participate in the study from up to 20 investigator sites.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.
- The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.
- The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent, with no size limitation for OviTex IHR.
- Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
- Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
- Subject is able to complete Quality of Life (QoL) and pain questionnaires.
- Subject is at least 21 years old.
- Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.
Exclusion criteria
- at Baseline:
- Subject has a BMI of \> 40
- Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
- Subject is female and is pregnant or plans to become pregnant during the course of the study.
- Subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
- Subject has recent history of drug or alcohol abuse (in last 3 years).
- Subject has an allergy to ovine-derived products.
- Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
- Subject has a strangulated hernia. Exclusion Criteria Intraoperative:
- Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
- Subject unable to receive OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR at time of surgery.
Where
- Mobile, Alabama
- Denver, Colorado
- Destin, Florida
- Fort Myers, Florida
- Overland Park, Kansas
- Louisville, Kentucky
- Traverse City, Michigan
- Roslyn, New York
- Utica, New York
- Houston, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations