Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

NCT ID: NCT01816867

Last Updated: 2015-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

96 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-01-31

Study Completion Date

2014-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ventral Hernia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with a ventral hernia

Intramesh T1 implantation

Intervention Type DEVICE

Interventions

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Intramesh T1 implantation

Intervention Type DEVICE

Other Intervention Names

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Intramesh T1 Cousin Biotech

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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be Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt Van der Speeten, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Ziekenhuis Oost-Limburg

Locations

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Ziekenhuis Oost-Limburg

Genk, Limburg, Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 28438090 (View on PubMed)

Other Identifiers

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BM-T1-08

Identifier Type: -

Identifier Source: org_study_id

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