Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
NCT ID: NCT04779918
Last Updated: 2025-10-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2021-04-29
2027-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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OviTex Reinforced Tissue Matrix
This is a single-arm study. All study subjects will receive OviTex.
OviTex Reinforced Tissue Matrix
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.
Interventions
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OviTex Reinforced Tissue Matrix
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
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Inclusion Criteria
2. The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent.
3. 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.
4. Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
5. 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.
6. Subject is able to complete Quality of Life (QoL) and pain questionnaires.
7. Subject is at least 21 years old.
8. 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
2. Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
3. Subject is female and is pregnant or plans to become pregnant during the course of the study.
4. Subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
5. Subject has recent history of drug or alcohol abuse (in last 3 years).
6. Subject has an allergy to ovine-derived products.
7. Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
8. Subject has a strangulated hernia.
1. Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
2. Subject unable to receive OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent time of surgery.
21 Years
ALL
Yes
Sponsors
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MCRA
INDUSTRY
Tela Bio Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Geoffrey Slayden, MD
Role: PRINCIPAL_INVESTIGATOR
St. Lukes Hospital
Locations
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University of South Alabama
Mobile, Alabama, United States
SurgOne
Denver, Colorado, United States
GenesisCare
Destin, Florida, United States
Surgical Healing Arts Center
Fort Myers, Florida, United States
St. Luke's Hospital
Overland Park, Kansas, United States
University of Louisville
Louisville, Kentucky, United States
Munson Healthcare
Traverse City, Michigan, United States
St. Francis Hospital
Roslyn, New York, United States
Mohawk Valley Health System
Utica, New York, United States
Houston Methodist
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TB.2020.01.01
Identifier Type: -
Identifier Source: org_study_id
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