Clinical trial NCT04779918: Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh
Official title: A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hernia, Ventral
Hernia, Inguinal
Keywords: use of mesh
robotic hernia repair
Lead sponsor: Tela Bio Inc
Sponsor class: INDUSTRY
Collaborators: name: MCRA
First posted: 2021-03-03
Enrollment: 160
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Early surgical site occurrences or wound related events
timeFrame: occurring within the first 3 months of the ventral or inguinal hernia repair
measure: Early post-operative complications
timeFrame: occurring within the first 3 months of the ventral or inguinal hernia repair.
Secondary outcomes:
measure: Late surgical site occurrences or wound related events
timeFrame: occurring > 3 months after index surgery
measure: Late post-operative complications
timeFrame: occurring > 3 months after index surgery.
measure: Patient Reported Outcomes
timeFrame: Assessed at day 30, day 90, 12 months, and 24 months post-op
measure: Hernia Recurrence
timeFrame: at post-operative day 90 and months 12 and 24
Other outcomes:
Locations:
city: Denver
country: United States
facility: SurgOne
state: Colorado
city: Destin
country: United States
facility: GenesisCare
state: Florida
city: Fort Myers
country: United States
facility: Surgical Healing Arts Center
state: Florida
city: Overland Park
country: United States
facility: St. Luke's Hospital
state: Kansas
city: Louisville
country: United States
facility: University of Louisville Surgical Oncology
state: Kentucky
city: Traverse City
country: United States
facility: Munson Healthcare
state: Michigan
city: Roslyn
country: United States
facility: St. Francis Hospital
state: New York
city: Houston
country: United States
facility: Houston Methodist
state: Texas
Study officials:
affiliation: St. Lukes Hospital
name: Geoffrey Slayden, MD
role: PRINCIPAL_INVESTIGATOR
References: