Evaluating Clinical Hiatal Hernia Outcomes Using OviTex®

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Tela Bio Inc
Study ID
NCT07070115
Status
Recruiting
Apply to this trial

Conditions

  • Hiatal Hernia

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • OviTex Reinforced Tissue Matrix — DEVICE
    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.

Study Details

This study will evaluate hiatal hernia recurrence rate and post-operative complications following the use of OviTex Core Resorbable or OviTex 1S Resorbable.

Key Dates

Start date
Jul 25, 2025
Status verified
Feb 2026
Primary completion
Dec 31, 2031
Completion
Jul 31, 2032

Study Design

Enrollment
173 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: OviTex Reinforced Tissue Matrix
    This is a single-arm study. All study subjects will receive OviTex.

Primary Outcome Measure

Hernia recurrence [ Time Frame: At 24 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of South Alabama HealthMobileAlabama36617
Valrie Patterson, RN
[email protected]
251-445-9626
William O Richards, MD (PRINCIPAL_INVESTIGATOR)
The University of Texas at Austin - Dell Medical SchoolAustinTexas78712
Swetha Venkataraman
[email protected]
512-495-2201
F.P. Tripp Buckley III, MD, FACS, FAFS (PRINCIPAL_INVESTIGATOR)

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University of South Alabama Health· Mobile, ALThe University of Texas at Austin - Dell Medical School· Austin, TX

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