Ventral or Inguinal Hernia, Robotically Repaired With OviTex Mesh

Hernia, Inguinal Clinical Trial

— BRAVOII  

Official title:

A Prospective Study Evaluating the Clinical Outcomes of Ventral or Inguinal Hernias Treated Robotically With OviTex® Reinforced Tissue Matrix

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04779918
• Other study ID #: TB.2020.01.01
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Hernia, Ventral

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