A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hernia, Ventral
- Sponsor
- Tela Bio Inc
- Enrollment
- 160
- Locations
- 10
- Primary Endpoint
- Early surgical site occurrences or wound related events
- Status
- Recruiting
- Last Updated
- 6 months ago
Overview
Brief 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.
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.
Investigators
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, or OviTex 1S Permanent.
- •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.
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Early surgical site occurrences or wound related events
Time Frame: occurring within the first 3 months of the ventral or inguinal hernia repair
Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site
Early post-operative complications
Time Frame: occurring within the first 3 months of the ventral or inguinal hernia repair.
Incidence of other early post-operative complications
Secondary Outcomes
- Late surgical site occurrences or wound related events(occurring > 3 months after index surgery)
- Patient Reported Outcomes(Assessed at day 30, day 90, 12 months, and 24 months post-op)
- Late post-operative complications(occurring > 3 months after index surgery.)
- Hernia Recurrence(at post-operative day 90 and months 12 and 24)