Ventral Hernia Study Using OviTex Reinforced Bioscaffold

NCT03074474 | Completed Results FDA Device

• 1 other identifier: TB2016.01.01
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 7

Brief Summary

The study is designed to demonstrate that the use of OviTex® 1S material for a ventral hernia repair leads to the same or a lower percentage of early post-operative complications and true hernia recurrences when compared to other types of available meshes. 100 subjects will be included from 5-7 participating investigator sites. Within 30 days prior to the hernia repair surgery, a baseline visit will be performed during which the patient's eligibility for the study will be evaluated. The surgical technique used for the repair will be determined by the investigator/surgeon. Additional study data will be collected during the hospital stay, 30 and 90 days post-operatively and 12 and 24 months post-operatively. At the follow up visits, the surgical site will be evaluated by the surgeon, both the surgeon and patient will be asked to rate their satisfaction with the repair and the subject will be asked to complete two Quality of Life questionnaires.

Conditions

Hernia, Ventral

Keywords

use of mesh

Outcome Measures

Primary Outcomes (1)

• Surgical Site Occurrences or Wound-related Events

  The primary endpoints were number of participants experiencing an SSO or wound related event at the hernia repair site and the number of participants experiencing other complications \<90 days after index surgery. These included seromas, hematomas, wound dehiscence, skin necrosis, fistulae, and infections. Complications such as ileus and bowel obstruction were also recorded.

  within the first three months of the ventral hernia repair

Secondary Outcomes (4)

• Hernia Recurrence, Post-operative SSO, and Wound Related Events at the Hernia Repair Site Occurring at Time Points > 90 Days After Index Surgery

  Overall Cumulative SSOs and Complications (0 - 24 Months)

• Change in Patient Reported Outcomes (HerQLes) From Baseline to Each Time Point

  Baseline through 24 months

• Change in Patient Reported Outcomes (EQ-5D VAS) From Baseline to Each Time Point

  Baseline through 24 Months

• Change in Patient Reported Outcomes (EQ-5D Index) From Baseline to Each Time Point

  Baseline through 24 Months

Study Arms (1)

OviTex Permanent 1S

OTHER

All subjects included in this post-market study had a ventral hernia repaired with OviTex 1S Permanent reinforced tissue matrix.

Device: OviTex 1S Permanent

Interventions

OviTex 1S Permanent DEVICE

OviTex 1S Permanent is a reinforced tissue matrix consisting of layers of extra-cellular matrix derived from sheep stomachs. The layers are embroidered together with a monofilament polypropylene. One side of the mesh has blue polypropylene stitching, which provides a surface conducive to native tissue growth. The other side of the mesh is a smooth surface intended to minimize tissue attachment (adhesions).

OviTex Permanent 1S

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject suffers from an uncomplicated ventral hernia that requires surgical repair (open, laparoscopic, or robotic) with the use of an implant to reinforce or replace weakened or missing tissue.
• The size of the implant needed for repair is expected to be 18 x 22 cm, 20 x 20 cm or less.
• Subject meets CDC/SSI Wound Classification Class I (Clean), Class II (Clean-Contaminated) or Class III (Contaminated) criteria
• 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.
• Subject is able to complete Quality of Life (QoL) and pain Questionnaires.
• Subject is at least 18 years old (or considered an adult per state law).
• Subject is able to participate fully in, and for the full duration of, the study.

You may not qualify if:

• Subject has a BMI of \> 40.
• Subject meets CDC/SSI Wound Classification Class IV(Dirty-Infected) criteria.
• Subject is female and is pregnant.
• Subject has a life expectancy of \< 2 years making it unlikely that the subject will successfully achieve two-year follow-up.
• Subject has recent history of drug or alcohol abuse (in last 3 years).
• Subject has an allergy to ovine-derived products.
• Subject has participated in another clinical trial within the past 30 days or is currently involved in another clinical trial.
• Subject is unable to receive OviTex® Permanent 1S reinforced bioscaffold at the time of surgery.
• Subject requires implant that exceeds 18 x 22 cm or 20 x 20 cm.
• Subject unable to receive OviTex® Permanent 1S reinforced bioscaffold at time of surgery.

Sponsors & Collaborators

• Tela Bio Inc: lead

Study Sites (7)

Scripps Clinic

La Jolla, California, 92037, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

St. Luke's Hospital South

Overland Park, Kansas, 66213, United States

Location

Capital Health

Trenton, New Jersey, 08638, United States

Location

St. Francis Hosptial

Roslyn, New York, 11576, United States

Location

Comanche County Memorial Hospital

Lawton, Oklahoma, 73505, United States

Location

Related Publications (2)

• DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. 24-Month results of the BRAVO study: A prospective, multi-center study evaluating the clinical outcomes of a ventral hernia cohort treated with OviTex(R) 1S permanent reinforced tissue matrix. Ann Med Surg (Lond). 2022 Sep 27;83:104745. doi: 10.1016/j.amsu.2022.104745. eCollection 2022 Nov.

  PMID: 36389188 DERIVED

• DeNoto G 3rd, Ceppa EP, Pacella SJ, Sawyer M, Slayden G, Takata M, Tuma G, Yunis J. A Prospective, Single Arm, Multi-Center Study Evaluating the Clinical Outcomes of Ventral Hernias Treated with OviTex(R) 1S Permanent Reinforced Tissue Matrix: The BRAVO Study 12-Month Analysis. J Clin Med. 2021 Oct 27;10(21):4998. doi: 10.3390/jcm10214998.

  PMID: 34768516 DERIVED

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Neal Overbeck
• Organization: TELA Bio

noverbeck@telabio.com

484-802-9570

Study Officials

• George DeNoto, MD

  Saint Francis Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2017
• First Posted: March 8, 2017
• Study Start: April 24, 2017
• Primary Completion: December 8, 2019
• Study Completion: August 8, 2021
• Last Updated: June 13, 2023
• Results First Posted: June 13, 2023

Record last verified: 2023-06

Locations

US (7)