A Prospective Study Evaluating Clinical Hiatal Hernia Outcomes Using OviTex® Reinforced Tissue Matrix
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Healthy Volunteers: f
View:
• Patient is a candidate for an elective robotic or laparoscopic primary hiatal hernia repair with the use of OviTex Core Resorbable or OviTex 1S Resorbable.
• Patient is willing and able to voluntarily sign the IRB-approved Informed Consent Form for the study.
• Patient is at least 22 years old at the time of surgery.
• Patient is not pregnant and not planning to become pregnant during the duration of the study (5 years).
• Patient is able and willing to comply with the study requirements including completion of patient questionnaires and clinic evaluations.
Locations
United States
Alabama
University of South Alabama Health
RECRUITING
Mobile
Texas
The University of Texas at Austin - Dell Medical School
RECRUITING
Austin
Contact Information
Primary
Melissa LaMantia, MA
mlamantia@telabio.com
757-761-4922
Backup
Danielle Campbell
dcampbell@telabio.com
717-676-2589
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2032-07-31
Participants
Target number of participants: 133
Treatments
Other: OviTex Reinforced Tissue Matrix
This is a single-arm study. All study subjects will receive OviTex.
Related Therapeutic Areas
Sponsors
Leads: Tela Bio Inc