Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Tela Bio Inc
Study ID
NCT04779918
Status
Recruiting
Apply to this trial

Conditions

  • Hernia, Inguinal
  • Hernia, Ventral

Eligibility Criteria

Sex
ALL
Age
21 Years - N/A
Healthy Volunteers
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 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.

Key Dates

Start date
Apr 29, 2021
Status verified
Apr 2026
Primary completion
Mar 30, 2027
Completion
Dec 30, 2029

Study Design

Enrollment
160 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

Early surgical site occurrences or wound related events [ Time Frame: occurring within the first 3 months of the ventral or inguinal hernia repair ]

Central Contacts

Locations (10)

FacilityCityStateZIPSite coordinators
University of South AlabamaMobileAlabama36617
Valrie Patterson, RN
[email protected]
251-445-9626
Daniel McMahon, MD (PRINCIPAL_INVESTIGATOR)
SurgOneDenverColorado802210-
GenesisCareDestinFlorida325541-
Surgical Healing Arts CenterFort MyersFlorida33912-
St. Luke's HospitalOverland ParkKansas66213-
University of LouisvilleLouisvilleKentucky40202
Dajana Nenadovic, RN
[email protected]
502-588-4571
Farid Kehdy, MD (PRINCIPAL_INVESTIGATOR)
Munson HealthcareTraverse CityMichigan49684
Kelly VanSchouwen
[email protected]
Joel Strehl, DO (PRINCIPAL_INVESTIGATOR)
St. Francis HospitalRoslynNew York11576-
Mohawk Valley Health SystemUticaNew York13502-
Houston MethodistHoustonTexas77030-

Find similar trials in Mobile, AL

By research site
University of South Alabama· Mobile, ALSurgOne· Denver, COGenesisCare· Destin, FLSurgical Healing Arts Center· Fort Myers, FLSt. Luke's Hospital· Overland Park, KSUniversity of Louisville· Louisville, KY

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