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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04779918
Other study ID # TB.2020.01.01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 14, 2021
Est. completion date June 30, 2027

Study information

Verified date September 2023
Source Tela Bio Inc
Contact Zachary Sterner
Phone 937-514-2262
Email zsterner@telabio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 160
Est. completion date June 30, 2027
Est. primary completion date December 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
OviTex Reinforced Tissue Matrix
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.

Locations

Country Name City State
United States SurgOne Denver Colorado
United States GenesisCare Destin Florida
United States Surgical Healing Arts Center Fort Myers Florida
United States Houston Methodist Houston Texas
United States St. Luke's Hospital Overland Park Kansas
United States St. Francis Hospital Roslyn New York
United States Munson Healthcare Traverse City Michigan

Sponsors (2)

Lead Sponsor Collaborator
Tela Bio Inc MCRA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Early surgical site occurrences or wound related events Incidence of early peri- and post-operative surgical site occurrences or wound related events noted at the hernia repair site occurring within the first 3 months of the ventral or inguinal hernia repair
Primary Early post-operative complications Incidence of other early post-operative complications occurring within the first 3 months of the ventral or inguinal hernia repair.
Secondary Late surgical site occurrences or wound related events Incidence of late post-operative surgical site occurrences or wound related events noted at the hernia repair site occurring > 3 months after index surgery
Secondary Late post-operative complications Incidence of other late post-operative complications occurring > 3 months after index surgery.
Secondary Patient Reported Outcomes Patient Reported Outcomes (QoL and pain assessments) Assessed at day 30, day 90, 12 months, and 24 months post-op
Secondary Hernia Recurrence True hernia recurrence at the site of surgery at post-operative day 90 and months 12 and 24
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