A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Tela Bio Inc
- Enrollment
- 160
- Locations
- 15
- Primary Endpoint
- Early surgical site occurrences or wound related events
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
OviTex Reinforced Tissue Matrix
This is a single-arm study. All study subjects will receive OviTex.
Intervention: OviTex Reinforced Tissue Matrix (Device)
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)