NCT02720042

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
8 countries

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 11, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 23, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2019

Completed
12 months until next milestone

Results Posted

Study results publicly available

June 17, 2020

Completed
Last Updated

September 25, 2020

Status Verified

September 1, 2020

Enrollment Period

1.4 years

First QC Date

February 11, 2016

Results QC Date

May 29, 2020

Last Update Submit

September 4, 2020

Conditions

HerniaHernia, AbdominalHernia, Incisional

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With One or More Surgical Site Occurrence Within 3 Months of Index Procedure

    Proportions of subjects with Surgical Site Occurrences, which are defined as hematoma, seroma, surgical site infection, wound dehiscence, skin necrosis and fistula requiring intervention. Occurrences at the surgical site will be assessed by physical examination at each study visit through 3 months. For analysis purposes, the aggregate Surgical Site Occurrence is defined as follows: "The question \<Is there any evidence of surgical site occurrence (SSO) in the same location as the index procedure?\> is answered with \<yes\>

    3 Months

Secondary Outcomes (11)

  • Number of Participants With One or More Surgical Site Occurrence Within 24 Months of Index Procedure

    24 Months

  • Number of Participants With a Hernia Recurrence

    24 Months

  • Number of Participants With One or More Surgical Site Infection

    24 Months

  • Mean Change in Pain Between Baseline (Pre-Index Procedure) and 24 Months Post-Index Procedure, as Measured by a 10.0 cm Visual Analogue Scale

    24 Months

  • Number of Participants With One or More Device-related Adverse Event

    24 Months

  • +6 more secondary outcomes

Study Arms (1)

Phasix™ Mesh

EXPERIMENTAL

Patients treated with Phasix™ Mesh for hernia repair

Device: Phasix™ Mesh

Interventions

Phasix™ MeshDEVICE

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

Phasix™ Mesh

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Wilhelminenspital

Vienna, Austria

Location

Imelda Ziekenhuis

Bonheiden, Belgium

Location

UZ Gent

Ghent, Belgium

Location

UZ Leuven (Gasthuisberg)

Leuven, Belgium

Location

Bispebjerg Hospital

Copenhagen, Denmark

Location

Centre Hospitalier Régional Universitaire de Lille

Lille, France

Location

APHP Hôpital Cochin

Paris, France

Location

Day Surgery and Hernia Center

Cottbus, Brandenburg, Germany

Location

Vivantes Hospital

Berlin, Germany

Location

Klinikum der Johann Wolfgang Goethe-Universität

Frankfurt, Germany

Location

Policlinico Umberto I

Roma, Italy

Location

IJsselland Ziekenhuis

Capelle aan den IJssel, Netherlands

Location

Elkerliek Ziekenhuis

Helmond, Netherlands

Location

Isala

Zwolle, Netherlands

Location

University College London Hospitals NHS Trust

London, United Kingdom

Location

Related Publications (2)

  • 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.

    PMID: 34282506DERIVED

  • 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.

    PMID: 30458747DERIVED

MeSH Terms

Conditions

HerniaHernia, AbdominalIncisional Hernia

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic Processes

Results Point of Contact

Title
Sandra van Guldener
Organization
Becton, Dickinson and Company
sandra.vanguldener@bd.com
+31 6 46900840

Study Officials

  • Hans Jeekel

    Erasmus University Medical Centre Rotterdam

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

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

February 11, 2016

First Posted

March 25, 2016

Study Start

March 23, 2016

Primary Completion

July 31, 2017

Study Completion

June 20, 2019

Last Updated

September 25, 2020

Results First Posted

June 17, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)FR(2)BE(3)AU(1)IT(1)GB(1)DE(3)NL(3)