Ventral Hernia Study Using OviTex Reinforced Bioscaffold

Part of paid clinical trials in La Jolla, California.

Sponsor
Tela Bio Inc
Study ID
NCT03074474
Status
Completed

Conditions

  • Hernia, Ventral

Eligibility Criteria

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

Interventions

  • OviTex 1S Permanent — DEVICE
    OviTex 1S Permanent is a reinforced tissue matrix consisting of layers of extra-cellular matrix derived from sheep stomachs. The layers are embroidered together with a monofilament polypropylene. One side of the mesh has blue polypropylene stitching, which provides a surface conducive to native tissue growth. The other side of the mesh is a smooth surface intended to minimize tissue attachment (adhesions).

Study Details

The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.

Key Dates

First listed
Mar 8, 2017
Start date
Apr 24, 2017
Status verified
Jun 2023
Primary completion
Dec 8, 2019
Completion
Aug 8, 2021

Study Design

Enrollment
92 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: OviTex Permanent 1S
    All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.

Primary Outcome Measure

Surgical Site Occurrences or Wound-related Events [ Time Frame: within the first three months of the ventral hernia repair ]

Locations (7)

FacilityCityStateZIPSite coordinators
Scripps ClinicLa JollaCalifornia92037-
Sarasota Memorial HospitalSarasotaFlorida34239-
Indiana University School of MedicineIndianapolisIndiana46202-
St. Luke's Hospital SouthOverland ParkKansas66213-
Capital HealthTrentonNew Jersey08638-
St. Francis HosptialRoslynNew York11576-
Comanche County Memorial HospitalLawtonOklahoma73505-

Find similar trials in La Jolla, CA

By research site
Scripps Clinic· La Jolla, CASarasota Memorial Hospital· Sarasota, FLIndiana University School of Medicine· Indianapolis, INSt. Luke's Hospital South· Overland Park, KSCapital Health· Trenton, NJSt. Francis Hosptial· Roslyn, NY

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