RecruitingNot ApplicableNCT04779918

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix


Sponsor

Tela Bio Inc

Enrollment

160 participants

Start Date

Apr 29, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This study is tracking outcomes for patients having robotic hernia repair surgery using OviTex mesh — a reinforcement material made from a combination of synthetic fibers and processed sheep tissue. Both ventral hernias (in the abdominal wall) and inguinal hernias (in the groin) are included. Hernias occur when tissue or organs push through a weak point in muscle, and mesh is commonly used to strengthen the repair and lower the risk of recurrence. The study collects information about pain levels, quality of life, and whether the hernia returns over a two-year follow-up period. This real-world data helps surgeons understand how OviTex performs in a variety of patients. You may be eligible if: - You are 21 years or older - You have a ventral or inguinal hernia requiring surgical repair with an implant - You are scheduled for elective robotic hernia repair using OviTex mesh - Your wound is classified as clean or only mildly contaminated You may NOT be eligible if: - Your BMI is over 40 - Your wound is classified as dirty or infected - You have a strangulated hernia - You are pregnant or planning to become pregnant during the study - You have an allergy to sheep-derived (ovine) products - Your life expectancy is less than 2 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEOviTex 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.


Locations(10)

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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04779918


Related Trials