Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
BRAVOII
A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
1 other identifier
interventional
160
1 country
10
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2021
CompletedFirst Posted
Study publicly available on registry
March 3, 2021
CompletedStudy Start
First participant enrolled
April 29, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2029
May 5, 2026
April 1, 2026
5.9 years
February 26, 2021
April 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Early surgical site occurrences or wound related events
Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site
occurring within the first 3 months of the ventral or inguinal hernia repair
Early post-operative complications
Incidence of other early post-operative complications
occurring within the first 3 months of the ventral or inguinal hernia repair.
Secondary Outcomes (4)
Late surgical site occurrences or wound related events
occurring > 3 months after index surgery
Late post-operative complications
occurring > 3 months after index surgery.
Patient Reported Outcomes
Assessed at day 30, day 90, 12 months, and 24 months post-op
Hernia Recurrence
at post-operative day 90 and months 12 and 24
Study Arms (1)
OviTex Reinforced Tissue Matrix
OTHERThis is a single-arm study. All study subjects will receive OviTex.
Interventions
All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tela Bio Inclead
- MCRAcollaborator
Study Sites (10)
University of South Alabama
Mobile, Alabama, 36617, United States
SurgOne
Denver, Colorado, 802210, United States
GenesisCare
Destin, Florida, 325541, United States
Surgical Healing Arts Center
Fort Myers, Florida, 33912, United States
St. Luke's Hospital
Overland Park, Kansas, 66213, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Munson Healthcare
Traverse City, Michigan, 49684, United States
St. Francis Hospital
Roslyn, New York, 11576, United States
Mohawk Valley Health System
Utica, New York, 13502, United States
Houston Methodist
Houston, Texas, 77030, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Geoffrey Slayden, MD
St. Lukes Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 3, 2021
Study Start
April 29, 2021
Primary Completion (Estimated)
March 30, 2027
Study Completion (Estimated)
December 30, 2029
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share