Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Launched by TELA BIO INC · Feb 26, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a specific type of mesh, called OviTex, used in robotic surgery for repairing ventral (belly) or inguinal (groin) hernias. Researchers want to find out how well this mesh works in preventing complications and whether it helps stop the hernias from coming back after surgery. Up to 160 people will take part in this study across about 20 locations.

To be eligible for this trial, participants need to be at least 21 years old and have a ventral or inguinal hernia that requires surgery using the OviTex mesh. They should also be able to complete some questionnaires about their health and pain. However, there are a few reasons someone might not qualify, such as having a very high body mass index (BMI), being pregnant, or having certain medical conditions. Those who join the study can expect to undergo robotic surgery and will be followed up to see how they recover and whether the hernia returns. This trial is currently recruiting participants, and everyone will need to provide their consent to take part in the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 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. The patient is scheduled for an elective robotic approach with the use of OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent.
• • 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. Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria.
• • 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. Subject is able to complete Quality of Life (QoL) and pain questionnaires.
• • 7. Subject is at least 21 years old.
• • 8. 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:
• • 1. Subject has a BMI of \> 40
• • 2. Subject meets CDC/SSI Wound Classification Class IV (Dirty-Infected) criteria
• • 3. Subject is female and is pregnant or plans to become pregnant during the course of the study.
• • 4. Subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
• • 5. Subject has recent history of drug or alcohol abuse (in last 3 years).
• • 6. Subject has an allergy to ovine-derived products.
• • 7. Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
• • 8. Subject has a strangulated hernia.
• Exclusion Criteria Intraoperative:
• • 1. Subject requires implant that cannot be introduced into the surgical site during the procedure via port or an existing incision.
• • 2. Subject unable to receive OviTex LPR, OviTex Core Permanent, or OviTex 1S Permanent time of surgery.