Hernia, Inguinal, Hernia, Ventral
Conditions
Keywords
use of mesh, robotic hernia repair
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.
Interventions
All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.
Sponsors
Tela Bio Inc
MCRA
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes
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, OviTex 1S Permanent, or OviTex IHR. 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, with no size limitation for OviTex IHR. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Early surgical site occurrences or wound related events | 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 | occurring within the first 3 months of the ventral or inguinal hernia repair. | Incidence of other early post-operative complications |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Late surgical site occurrences or wound related events | occurring > 3 months after index surgery | Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site |
| Late post-operative complications | occurring > 3 months after index surgery. | Incidence of other late post-operative complications |
| Patient Reported Outcomes | Assessed at day 30, day 90, 12 months, and 24 months post-op | Patient Reported Outcomes (QoL and pain assessments) |
| Hernia Recurrence | at post-operative day 90 and months 12 and 24 | True hernia recurrence at the site of surgery |
Countries
United States
Contacts
CONTACTMelissa LaMantia
CONTACTDanielle Campbell
PRINCIPAL_INVESTIGATORGeoffrey Slayden, MD
St. Lukes Hospital
Outcome results
None listed