NCT01816867

Brief Summary

The purpose of the registry is to evaluate safety and efficacy of the Intramesh T1. This registry will collect data from 100 patients treated for a ventral hernia repair.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 22, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

May 22, 2015

Status Verified

May 1, 2015

Enrollment Period

1.7 years

First QC Date

March 20, 2013

Last Update Submit

May 21, 2015

Conditions

Ventral Hernia

Keywords

herniaTreatmentlaparoscopicopen technique

Outcome Measures

Primary Outcomes (1)

  • Recurrence rate at 12 months determined by clinical examination

    12 months

Secondary Outcomes (5)

  • Intraoperative complications

    peri-procedural

  • Post-operative complications

    up to 30 days

  • Seroma

    1 month

  • Freedom from hernia-related reinterventions

    12 months

  • Late complications

    12 months

Study Arms (1)

Patients with a ventral hernia

Device: Intramesh T1 implantation

Interventions

Intramesh T1 implantationDEVICE
Also known as: Intramesh T1 Cousin Biotech
Patients with a ventral hernia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a ventral hernia

You may qualify if:

  • Patient is older than 18 years
  • Written informed consent is obtained from patient
  • Patient with a primary or incisional ventral hernia

You may not qualify if:

  • Patient with a recurrent ventral hernia
  • Patient with ASA class 5 and 6
  • Patient underwent emergency surgery
  • Patient is pregnant
  • Patient with a known allergy to components of the ePTFE prosthesis
  • Patient has a life expectancy less than 1 year
  • Patient is unable to be compliant with the follow-up visits due to geographical, social or psychological factors

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ziekenhuis Oost-Limburg

Genk, Limburg, 3600, Belgium

Location

Related Publications (1)

  • Wen W, Majerus B, Van De Moortel M, Lobue S, Fobe D, Philippart P, Berwouts L, Coteur J, Gabriels K, Van der Speeten K. Laparoscopic ventral hernia repair using a composite mesh with polypropylene and expanded polytetrafluoroethylene: a prospective, multicentre registry. Acta Chir Belg. 2017 Oct;117(5):295-302. doi: 10.1080/00015458.2017.1313526. Epub 2017 Apr 25.

    PMID: 28438090DERIVED

MeSH Terms

Conditions

Hernia, VentralHernia

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Kurt Van der Speeten, MD, PhD

    Ziekenhuis Oost-Limburg

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
12 Months
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2013

First Posted

March 22, 2013

Study Start

January 1, 2013

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

May 22, 2015

Record last verified: 2015-05

Locations

BE(1)