RECRUITING

Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

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Conditions

Hernia, VentralHernia, Inguinaluse of meshrobotic hernia repair

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-04-14
Study Completion:2027-12-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04779918

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:21 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. 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.
  2. 2. The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent.
  3. 3. 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.
  4. 4. Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
  5. 5. 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.
  6. 6. Subject is able to complete Quality of Life (QoL) and pain questionnaires.
  7. 7. Subject is at least 21 years old.
  8. 8. Subject is willing to comply and able to participate fully in, and for the full duration of, the study including follow-up requirements.
  9. 1. Subject has a BMI of \> 40
  10. 2. Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
  11. 3. Subject is female and is pregnant or plans to become pregnant during the course of the study.
  12. 4. Subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
  13. 5. Subject has recent history of drug or alcohol abuse (in last 3 years).
  14. 6. Subject has an allergy to ovine-derived products.
  15. 7. Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
  16. 8. Subject has a strangulated hernia.
  17. 1. Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
  18. 2. Subject unable to receive OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent time of surgery.
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Melissa LaMantia
CONTACT
757-761-4922
mlamantia@telabio.com
Danielle Campbell
CONTACT
717-676-2589
dcampbell@telabio.com

Principal Investigator

Geoffrey Slayden, MD
PRINCIPAL_INVESTIGATOR
St. Lukes Hospital

Study Locations (Sites)

SurgOne
Denver, Colorado, 802210
United States
GenesisCare
Destin, Florida, 325541
United States
Surgical Healing Arts Center
Fort Myers, Florida, 33912
United States
St. Luke's Hospital
Overland Park, Kansas, 66213
United States
University of Louisville Surgical Oncology
Louisville, Kentucky, 40202
United States
Munson Healthcare
Traverse City, Michigan, 49684
United States
St. Francis Hospital
Roslyn, New York, 11576
United States
Houston Methodist
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Tela Bio Inc

  • Geoffrey Slayden, MD, PRINCIPAL_INVESTIGATOR, St. Lukes Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-04-14
Study Completion Date2027-12-30

Study Record Updates

Study Start Date2021-04-14
Study Completion Date2027-12-30

Terms related to this study

Keywords Provided by Researchers

  • use of mesh
  • robotic hernia repair

Additional Relevant MeSH Terms

  • Hernia, Ventral
  • Hernia, Inguinal