Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Not Applicable

Recruiting

• Conditions: Hernia, Inguinal; Hernia, Ventral
• Interventions: Device: OviTex Reinforced Tissue Matrix

• Registration Number: NCT04779918
• Lead Sponsor: Tela Bio Inc

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 Timeline

• Study First Submitted: 2021-02-26
• Study First Submitted QC: 2021-02-26
• Study First Posted: 2021-03-03
• Study Start: 2021-04-29
• Status Verified: 2024-12
• Last Update Submitted: 2025-01-08
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-03-30
• Study Completion: 2027-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
OviTex Reinforced Tissue Matrix	OviTex Reinforced Tissue Matrix	This is a single-arm study. All study subjects will receive OviTex.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Patient Reported Outcomes	Assessed at day 30, day 90, 12 months, and 24 months post-op	Patient Reported Outcomes (QoL and pain assessments)
Late post-operative complications	occurring > 3 months after index surgery.	Incidence of other late post-operative complications
Hernia Recurrence	at post-operative day 90 and months 12 and 24	True hernia recurrence at the site of surgery

Trial Locations

Locations (8)

SurgOne; 🇺🇸 Denver, Colorado, United States

GenesisCare; 🇺🇸 Destin, Florida, United States

Surgical Healing Arts Center; 🇺🇸 Fort Myers, Florida, United States

St. Luke's Hospital; 🇺🇸 Overland Park, Kansas, United States

University of Louisville Surgical Oncology; 🇺🇸 Louisville, Kentucky, United States

Munson Healthcare; 🇺🇸 Traverse City, Michigan, United States

St. Francis Hospital; 🇺🇸 Roslyn, New York, United States

Houston Methodist; 🇺🇸 Houston, Texas, United States