Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh (BRAVOII)
Primary Purpose
Hernia, Ventral, Hernia, Inguinal
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OviTex Reinforced Tissue Matrix
Sponsored by
About this trial
This is an interventional treatment trial for Hernia, Ventral focused on measuring use of mesh, robotic hernia repair
Eligibility Criteria
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 a robotic approach.
- The size of the implant needed for repair is expected to be less than 25 x 40 cm for OviTex Core and 1S and 12 x 18 cm for OviTex LPR.
- Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
- Subject has VHWG score of Grade 1, 2 or 3.
- 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 22 years old, (or considered an adult per state law).
- Subject is able to participate fully in, and for the full duration of, the study.
Exclusion Criteria at Baseline:
- Subject has a BMI of > 40
- Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
- Subject has VHWG score of Grade 4.
- Subject is female and is pregnant.
- 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.
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 Core Permanent, OviTex 1S Permanent, or OviTex LPR at the time of surgery.
Sites / Locations
- SurgOneRecruiting
- GenesisCareRecruiting
- Surgical Healing Arts CenterRecruiting
- St. Luke's HospitalRecruiting
- Munson HealthcareRecruiting
- St. Francis HospitalRecruiting
- Houston Methodist
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
OviTex Reinforced Tissue Matrix
Arm Description
This is a single-arm study. All study subjects will receive OviTex.
Outcomes
Primary Outcome Measures
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
Early post-operative complications
Incidence of other early post-operative complications
Secondary Outcome Measures
Late surgical site occurrences or wound related events
Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site
Late post-operative complications
Incidence of other late post-operative complications
Patient Reported Outcomes
Patient Reported Outcomes (QoL and pain assessments)
Hernia Recurrence
True hernia recurrence at the site of surgery
Full Information
NCT ID
NCT04779918
First Posted
February 26, 2021
Last Updated
September 11, 2023
Sponsor
Tela Bio Inc
Collaborators
MCRA
1. Study Identification
Unique Protocol Identification Number
NCT04779918
Brief Title
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
Acronym
BRAVOII
Official Title
A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2021 (Actual)
Primary Completion Date
December 30, 2024 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tela Bio Inc
Collaborators
MCRA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hernia, Ventral, Hernia, Inguinal
Keywords
use of mesh, robotic hernia repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
160 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
OviTex Reinforced Tissue Matrix
Arm Type
Other
Arm Description
This is a single-arm study. All study subjects will receive OviTex.
Intervention Type
Device
Intervention Name(s)
OviTex Reinforced Tissue Matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Early surgical site occurrences or wound related events
Description
Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site
Time Frame
occurring within the first 3 months of the ventral or inguinal hernia repair
Title
Early post-operative complications
Description
Incidence of other early post-operative complications
Time Frame
occurring within the first 3 months of the ventral or inguinal hernia repair.
Secondary Outcome Measure Information:
Title
Late surgical site occurrences or wound related events
Description
Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site
Time Frame
occurring > 3 months after index surgery
Title
Late post-operative complications
Description
Incidence of other late post-operative complications
Time Frame
occurring > 3 months after index surgery.
Title
Patient Reported Outcomes
Description
Patient Reported Outcomes (QoL and pain assessments)
Time Frame
Assessed at day 30, day 90, 12 months, and 24 months post-op
Title
Hernia Recurrence
Description
True hernia recurrence at the site of surgery
Time Frame
at post-operative day 90 and months 12 and 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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, or OviTex 1S Permanent.
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.
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, or OviTex 1S Permanent time of surgery.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zachary Sterner
Phone
937-514-2262
Email
zsterner@telabio.com
First Name & Middle Initial & Last Name or Official Title & Degree
Danielle Campbell
Phone
717-676-2589
Email
dcampbell@telabio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Geoffrey Slayden, MD
Organizational Affiliation
St. Lukes Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
SurgOne
City
Denver
State/Province
Colorado
ZIP/Postal Code
802210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly VanSchouwen
Email
kelly@researchtex.com
First Name & Middle Initial & Last Name & Degree
Thomas DeLine, MD
Facility Name
GenesisCare
City
Destin
State/Province
Florida
ZIP/Postal Code
325541
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shona Cataldo
Email
Shona.Cataldo@usa.genesiscare.com
First Name & Middle Initial & Last Name & Degree
Thomas Shaknovsky, MD
Facility Name
Surgical Healing Arts Center
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33912
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Mier y Leon
Email
alfredo@surgicalhealingarts.com
First Name & Middle Initial & Last Name & Degree
Moses Shieh, MD
Facility Name
St. Luke's Hospital
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patti Wyman
Email
pwyman@saint-lukes.org
First Name & Middle Initial & Last Name & Degree
Geoffrey Slayden, MD
Facility Name
Munson Healthcare
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly VanSchouwen
Email
kelly@researchtex.com
First Name & Middle Initial & Last Name & Degree
Joel Strehl, MD
Facility Name
St. Francis Hospital
City
Roslyn
State/Province
New York
ZIP/Postal Code
11576
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beth Schwartz
Email
Beth.Schwartz@chsli.org
First Name & Middle Initial & Last Name & Degree
George DeNoto, MD
Facility Name
Houston Methodist
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Active, not recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
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