Study of Phasix™ Mesh for VHWG Grade 3 Midline Hernia Repair

NCT ID: NCT02720042

Last Updated: 2020-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-23
• Study Completion Date: 2019-06-20

Brief Summary

The purpose of this study is to collect additional data on safety and performance of Phasix™ Mesh in subjects requiring Ventral Hernia Working Group (VHWG) Grade 3 midline hernia repair.

Detailed Description

Approximately 85 subjects, at approximately 12 sites across Europe will be enrolled and treated to study the use of Phasix™ Mesh. All treated subjects will be followed for 2 years post-implantation.

Conditions

Hernia; Hernia, Abdominal; Hernia, Incisional

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Phasix™ Mesh

Patients treated with Phasix™ Mesh for hernia repair

Group Type: EXPERIMENTAL

Phasix™ Mesh

Intervention Type: DEVICE

A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)

Interventions

Phasix™ Mesh

A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Subject must be diagnosed with incisional midline hernia.
• Subject has a VHWG Grade 3 hernia (as defined in the protocol).
• Size of hernia ≥ 10 cm2.
• Subject must be willing to undergo a planned retro-rectus hernia repair (onlay allowed as an exception when retro-rectus placement cannot be achieved; using absorbable suture) with or without Component Separation Technique.

Exclusion Criteria

• Subject with > 4 previous repairs of the hernia under observation.
• Body Mass Index (BMI) > 35 kg/m2.
• The subject is on, or suspected to be placed on, chemotherapy medications during any part of the study.
• The subject has peritonitis.
• Known human immunodeficiency virus (HIV) infection (if documented in the subject's record).
• The subject has cirrhosis of the liver and/or ascites.
• Subject is American Society of Anesthesiology Class 4 or 5.
• Complete removal of existing mesh from a prior hernia repair (in the same affected area) is not possible.
• The hernia repair requires more than a single piece mesh (with adequate overlap beyond the margins of the defect on all sides).
• Subject has intact permanent mesh adjacent to the current hernia to be repaired.
• Subject's hernia repair requires intraabdominal mesh placement.
• Surgical technique requires surgical bridge repair as the sole repair.
• Subject has any condition that, in the opinion of the Investigator, would preclude the use of the study device, or preclude the subject from completing the follow-up requirements.
• Subject is pregnant or has plans to become pregnant during the study period or is currently breastfeeding.
• Subject has an alcohol/substance abuse problem or has had a relapse within 12 months of the screening visit.
• Subject was involved in another interventional clinical study in the last 30 days prior to Informed Consent Form (ICF) signature.
• Subject is part of the site personnel directly involved with this study.
• Subject has a life expectancy of less than 2 years at the time of enrollment.
• Subject has a known sensitivity to Phasix™ Mesh or component materials (patients with known allergies to tetracycline hydrochloride or kanamycin sulfate should be avoided).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hans Jeekel

Role: PRINCIPAL_INVESTIGATOR

Erasmus University Medical Centre Rotterdam

Locations

Wilhelminenspital

Vienna, , Austria

Imelda Ziekenhuis

Bonheiden, , Belgium

UZ Gent

Ghent, , Belgium

UZ Leuven (Gasthuisberg)

Leuven, , Belgium

Bispebjerg Hospital

Copenhagen, , Denmark

Centre Hospitalier Régional Universitaire de Lille

Lille, , France

APHP Hôpital Cochin

Paris, , France

Day Surgery and Hernia Center

Cottbus, Brandenburg, Germany

Vivantes Hospital

Berlin, , Germany

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt, , Germany

Policlinico Umberto I

Roma, , Italy

IJsselland Ziekenhuis

Capelle aan den IJssel, , Netherlands

Elkerliek Ziekenhuis

Helmond, , Netherlands

Isala

Zwolle, , Netherlands

University College London Hospitals NHS Trust

London, , United Kingdom

Countries

Austria; Belgium; Denmark; France; Germany; Italy; Netherlands; United Kingdom

References

Van Rooijen MMJ, Tollens T, Jorgensen LN, de Vries Reilingh TS, Piessen G, Kockerling F, Miserez M, Windsor ACJ, Berrevoet F, Fortelny RH, Dousset B, Woeste G, van Westreenen HL, Gossetti F, Lange JF, Tetteroo GWM, Koch A, Jeekel J. Slowly resorbable biosynthetic mesh: 2-year results in VHWG grade 3 hernia repair. Hernia. 2022 Feb;26(1):131-138. doi: 10.1007/s10029-021-02453-1. Epub 2021 Jul 19.

Reference Type: DERIVED

PMID: 34282506 (View on PubMed)

van Rooijen MMJ, Jairam AP, Tollens T, Jorgensen LN, de Vries Reilingh TS, Piessen G, Kockerling F, Miserez M, Windsor ACJ, Berrevoet F, Fortelny RH, Dousset B, Woeste G, van Westreenen HL, Gossetti F, Lange JF, Tetteroo GWM, Koch A, Kroese LF, Jeekel J. A post-market, prospective, multi-center, single-arm clinical investigation of Phasix mesh for VHWG grade 3 midline incisional hernia repair: a research protocol. BMC Surg. 2018 Nov 20;18(1):104. doi: 10.1186/s12893-018-0439-7.

Reference Type: DERIVED

PMID: 30458747 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

DVL-HE-016

Identifier Type: -

Identifier Source: org_study_id