Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh (NCT04779918) | Clinical Trial Compass
RecruitingNot Applicable
Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
United States160 participantsStarted 2021-04-29
Plain-language summary
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.
Who can participate
Age range21 Years
SexALL
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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
✕. 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.
What they're measuring
1
Early surgical site occurrences or wound related events
Timeframe: occurring within the first 3 months of the ventral or inguinal hernia repair
2
Early post-operative complications
Timeframe: occurring within the first 3 months of the ventral or inguinal hernia repair.