Actively Recruiting
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
Led by Tela Bio Inc · Updated on 2026-05-05
160
Participants Needed
10
Research Sites
452 weeks
Total Duration
On this page
Sponsors
T
Tela Bio Inc
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial 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.
CONDITIONS
Official Title
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a ventral or inguinal hernia requiring surgical repair with an implant
- Scheduled for elective robotic hernia repair using OviTex LPR, Core Permanent, 1S Permanent, or IHR
- Implant size expected to be ≤15 x 25 cm for OviTex LPR or ≤25 x 40 cm for Core and 1S Permanent; no size limit for OviTex IHR
- Meet CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated), or Class III (Contaminated)
- Willing and able to sign informed consent
- Able to complete quality of life and pain questionnaires
- At least 21 years old
- Willing and able to fully participate and comply with study and follow-up requirements
You will not qualify if you...
- Body mass index (BMI) greater than 40
- Meet CDC/SSI Wound Classification Class IV (Dirty-Infected)
- Female who is pregnant or plans to become pregnant during the study
- Life expectancy less than 2 years
- Recent drug or alcohol abuse within the last 3 years
- Allergy to ovine-derived products
- Participated in another clinical trial within past 30 days or currently involved in another trial
- Have a strangulated hernia
- Require an implant that cannot be introduced via port or incision during surgery
- Unable to receive OviTex LPR, Core Permanent, 1S Permanent, or IHR at time of surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
University of South Alabama
Mobile, Alabama, United States, 36617
Actively Recruiting
2
SurgOne
Denver, Colorado, United States, 802210
Active, Not Recruiting
3
GenesisCare
Destin, Florida, United States, 325541
Terminated
4
Surgical Healing Arts Center
Fort Myers, Florida, United States, 33912
Terminated
5
St. Luke's Hospital
Overland Park, Kansas, United States, 66213
Active, Not Recruiting
6
University of Louisville
Louisville, Kentucky, United States, 40202
Actively Recruiting
7
Munson Healthcare
Traverse City, Michigan, United States, 49684
Actively Recruiting
8
St. Francis Hospital
Roslyn, New York, United States, 11576
Withdrawn
9
Mohawk Valley Health System
Utica, New York, United States, 13502
Withdrawn
10
Houston Methodist
Houston, Texas, United States, 77030
Active, Not Recruiting
Research Team
M
Melissa LaMantia
CONTACT
D
Danielle Campbell
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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