Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1

Ventral Hernia Clinical Trial

Official title:

Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01816867
• Other study ID #: BM-T1-08
• Status: Completed
• Phase: N/A
• First received: March 20, 2013
• Last updated: May 21, 2015
• Start date: January 2013
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: be Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: FAGG
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Ventral Hernia

Intervention

Device:
• Intramesh T1 implantation

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost-Limburg	Genk	Limburg

Sponsors (1)

Lead Sponsor	Collaborator
be Medical

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence rate at 12 months determined by clinical examination		12 months	No
Secondary	Intraoperative complications	Defined as complications occurring during index-procedure from "skin-into-skin". The following events must be reported in the case report form: enterotomy (bowel injury); major bleeding requiring blood transfusion or reintervention; complications due to anesthesia; minor bleeding at a trocar insertion site	peri-procedural	Yes
Secondary	Post-operative complications	Defined as complications up to 30 days after index-procedure. The following events should be reported in the case report form: local numbness; hematoma; seroma; superficial trocar site infection; mesh infection; hernia recurrence; death	up to 30 days	Yes
Secondary	Seroma	The rate of seroma at 1 month after index-procedure.	1 month	No
Secondary	Freedom from hernia-related reinterventions	Reinterventions at 12 months after index-procedure	12 months	No
Secondary	Late complications	Late complications at 12 months after index-procedure: prolonged pain more than 8 weeks; local numbness; hernia recurrence	12 months	Yes