Actively Recruiting
A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex Reinforced Tissue Matrix
Led by Tela Bio Inc · Updated on 2026-05-05
160
Participants Needed
10
Research Sites
143 weeks
Total Duration
On this page
Sponsors
T
Tela Bio Inc
Lead Sponsor
M
MCRA
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the post-operative complications and the recurrence of hernias in patients undergoing robotic repair of ventral or inguinal hernias using the OviTex reinforced tissue matrix. This single-arm study focuses on understanding the outcomes following this specific surgical mesh treatment. Up to 160 participants will be enrolled across multiple sites to gather comprehensive data on these surgical procedures. All participants will receive the OviTex reinforced tissue matrix as part of their hernia repair surgery using a robotic approach. Different types of OviTex implants may be used depending on the hernia, including OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR. The size of the implant varies by type, with some size limits for certain products. The study does not include a comparison group and focuses solely on patients treated with OviTex. Participants will be monitored for early and late surgical site occurrences and wound-related events, as well as post-operative complications within the first three months and beyond. Patient-reported outcomes such as quality of life and pain will be assessed up to 24 months after surgery. Hernia recurrence will also be evaluated at 90 days and at 12 and 24 months post-operation. The study involves follow-up visits and questionnaires to track these outcomes over time, with participation lasting up to two years.
CONDITIONS
Brief Title
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Suffer from a ventral or inguinal hernia requiring surgical repair with an implant to reinforce or replace weakened or missing tissue
- Scheduled for elective robotic surgery using OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR
- Implant size needed is expected to be ≤ 15 x 25 cm for OviTex LPR or ≤ 25 x 40 cm for OviTex Core Permanent and OviTex 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 in and comply with the 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 making two-year follow-up unlikely
- Recent history of drug or alcohol abuse in the last 3 years
- Allergy to ovine-derived products
- Participation in another clinical trial within the past 30 days or current involvement in another trial
- Strangulated hernia
- Requires implant that cannot be introduced via surgical ports or existing incisions
- Unable to receive the specified OviTex products at time of surgery
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery and initial recovery period
Participants undergo robotic surgical repair of ventral or inguinal hernias using OviTex Reinforced Tissue Matrix followed by immediate post-operative care.
1 surgical procedure and immediate post-operative hospital stay
Duration - Up to 3 months post-surgery
Participants are monitored for early post-operative complications and wound-related events, with assessments of surgical site occurrences and patient-reported outcomes.
Visits at post-operative day 30 and day 90
Duration - Up to 24 months post-surgery
Participants are monitored for late post-operative complications, hernia recurrence, and ongoing patient-reported outcomes.
Visits at 12 months and 24 months post-surgery
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
D
Danielle Campbell
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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