This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
This prospective, open-label, multicenter, non-randomized, post-market study will enroll up to 173 subjects in the United States. Patients undergoing an elective hiatal hernia repair and who meet all eligibility criteria will be enrolled in the study. Subjects will undergo minimally invasive procedures for hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable for reinforcement. Subjects will have clinical follow-up through 5 years. Data collected in this study will be compared to a literature control at 24 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
173
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.
University of South Alabama Health
Mobile, Alabama, United States
RECRUITINGSurgOne, PC
Denver, Colorado, United States
RECRUITINGUniversity of Kentucky
Lexington, Kentucky, United States
Hernia recurrence
Incidence of radiographic recurrence at 24 months, defined as \> 2cm above the hiatus via barium swallow.
Time frame: At 24 months
Early post-operative complications
Incidence of early post-operative device-related complications noted at the hernia repair site occurring ≤ 90 days after index hiatal hernia repair
Time frame: Occurring within the first 3 months of the hiatal hernia repair
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Wake Forest University Health Sciences
Charlotte, North Carolina, United States
RECRUITINGThe University of Texas at Austin - Dell Medical School
Austin, Texas, United States
RECRUITING