NCT00323141

Brief Summary

To study the advantages and disadvantages of a Ventralex prothesis versus Light Weight Vypro II prothesis in patients with a hernia umbilicalis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2016

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

First Submitted

Initial submission to the registry

May 7, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2006

Completed
9.8 years until next milestone

Study Start

First participant enrolled

March 11, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2017

Completed
Last Updated

December 7, 2022

Status Verified

December 1, 2022

Enrollment Period

1.5 years

First QC Date

May 7, 2006

Last Update Submit

December 6, 2022

Conditions

Hernia, Umbilical

Keywords

Hernia umbilicalis

Outcome Measures

Primary Outcomes (1)

  • Number of relapses after 1 and 3 years

    after 1 and 3 years

Secondary Outcomes (4)

  • Duration of surgery

    Depends from type of surgery.

  • Duration of hospitalisation

    Depends from type of surgery.

  • Frequency of complications

    After 1 and 3 years.

  • Pain assessment

    After 1 and 3 years.

Study Arms (2)

Ventralex

ACTIVE COMPARATOR
Device: Ventralex versus Leight Weight Vypro II prothesis

Leight Weight Vypro II prothesis

ACTIVE COMPARATOR
Device: Ventralex versus Leight Weight Vypro II prothesis

Interventions

Ventralex versus Leight Weight Vypro II prothesisDEVICE

Ventralex and Leight Weight Vypro II prothesis are compared.

Leight Weight Vypro II prothesisVentralex

Eligibility Criteria

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

You may qualify if:

  • Symptomatic hernia umbilicalis
  • \> 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Links

MeSH Terms

Conditions

Hernia, Umbilical

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHernia, VentralHernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Frederik Berrevoet, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2006

First Posted

May 9, 2006

Study Start

March 11, 2016

Primary Completion

August 31, 2017

Study Completion

August 31, 2017

Last Updated

December 7, 2022

Record last verified: 2022-12

Locations

BE(1)