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Recruiting NCT04779918

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

No phase Interventional Hernia, Ventral Hernia, Inguinal

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OviTex Reinforced Tissue Matrix.
Who it may be relevant to
Registry conditions: Hernia, Ventral, Hernia, Inguinal. Basic parameters: from 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix

Overview

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.

Detailed description

This study is intended to evaluate the post-operative complications and recurrence following the use of OviTex in ventral or inguinal hernias being treated robotically. It is a single-arm study and all subjects will receive OviTex.

Interventions

  • Device OviTex Reinforced Tissue Matrix
    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.

Primary outcome measures

  • Early surgical site occurrences or wound related events [Time frame: occurring within the first 3 months of the ventral or inguinal hernia repair]
  • Early post-operative complications [Time frame: occurring within the first 3 months of the ventral or inguinal hernia repair.]
Secondary outcome measures (4)
  • Late surgical site occurrences or wound related events [Time frame: occurring > 3 months after index surgery]
  • Late post-operative complications [Time frame: occurring > 3 months after index surgery.]
  • Patient Reported Outcomes [Time frame: Assessed at day 30, day 90, 12 months, and 24 months post-op]
  • Hernia Recurrence [Time frame: at post-operative day 90 and months 12 and 24]

Eligibility criteria

Inclusion criteria

  • Subject suffers from a ventral or inguinal hernia that requires surgical repair with the use of an implant to reinforce or replace weakened or missing tissue.
  • The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR.
  • The size of the implant needed for repair is expected to be less than or equal to 15 x 25 cm for OviTex LPR and 25 x 40 cm for OviTex Core Permanent and OviTex 1S Permanent, with no size limitation for OviTex IHR.
  • Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
  • Subject is willing and able to sign an informed consent for the study and has signed the IRB approved Informed Consent form for this study.
  • Subject is able to complete Quality of Life (QoL) and pain questionnaires.
  • Subject is at least 21 years old.
  • Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.

Exclusion Criteria at Baseline:

  • Subject has a BMI of > 40
  • Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
  • Subject is female and is pregnant or plans to become pregnant during the course of the study.
  • Subject has a life expectancy of < 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
  • Subject has recent history of drug or alcohol abuse (in last 3 years).
  • Subject has an allergy to ovine-derived products.
  • Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
  • Subject has a strangulated hernia.

Exclusion Criteria Intraoperative:

  • Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
  • Subject unable to receive OviTex LPR, OviTex Core Permanent, OviTex 1S Permanent, or OviTex IHR at time of surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • University of South Alabama — Mobile
  • SurgOne — Denver
  • GenesisCare — Destin
  • Surgical Healing Arts Center — Fort Myers
  • St. Luke's Hospital — Overland Park
  • University of Louisville — Louisville
  • Munson Healthcare — Traverse City
  • St. Francis Hospital — Roslyn
  • … and 2 more centers

Identifiers

NCT: NCT04779918 · TB.2020.01.01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗