Ventral HerniaNCT01816867
Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1
An observational study of Ventral Hernia, run by be Medical at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ventral Hernia
- What is being tested?
- Intramesh T1 implantation
- Type of treatment
- Medical device
- How many people
- 96 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2013to Oct 2014
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with a ventral hernia
Who may be able to join
- Patient is older than 18 years
- Written informed consent is obtained from patient
- Patient with a primary or incisional ventral hernia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry
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.
- Conditions
- Ventral Hernia
- Being tested
- Intramesh T1 implantation
- Keywords
- hernia, Treatment, laparoscopic, open technique
- Medical subject headings
- Hernia, Ventral, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intramesh T1 implantationDevice
Also called Intramesh T1 Cousin Biotech
| Study group | Role | What they receive |
|---|---|---|
| Patients with a ventral hernia | Not described Receives: Device: Intramesh T1 implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate at 12 months determined by clinical examination
Measured: 12 months
Secondary outcomes (5)
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
Measured: peri-procedural
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
Measured: up to 30 days
Seroma
The rate of seroma at 1 month after index-procedure.
Measured: 1 month
Freedom from hernia-related reinterventions
Reinterventions at 12 months after index-procedure
Measured: 12 months
Late complications
Late complications at 12 months after index-procedure:
- prolonged pain more than 8 weeks
- local numbness
- hernia recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2013 (estimated)
- Study startJan 2013
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 96 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- be Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Van der Speeten, MD, PhD, Principal investigator, Ziekenhuis Oost-Limburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01816867
- Sponsor's protocol ID
- BM-T1-08
- Status last verified
- May 2015
- First submitted
- 20 Mar 2013
- Last updated
- 22 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28438090
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic and Open Ventral Hernia Repair Using the Intramesh T1: a Prospective, Multicenter Registry
- ClinicalTrials.gov ID
- NCT01816867
- Acronym / sponsor ID
- BM-T1-08
- Conditions
- Ventral Hernia
- Keywords
- hernia, Treatment, laparoscopic, open technique
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- be MedicalIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 22 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a ventral hernia | – | Device: Intramesh T1 implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with a ventral hernia
Key inclusion criteria (3 listed)
- Patient is older than 18 years
- Written informed consent is obtained from patient
- Patient with a primary or incisional ventral hernia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intramesh T1 implantationAlso: Intramesh T1 Cousin Biotech | Device | Patients with a ventral hernia |
Primary outcome
Recurrence rate at 12 months determined by clinical examination
Time frame: 12 months
5 secondary outcomes
Intraoperative complications
Time frame: peri-procedural
Post-operative complications
Time frame: up to 30 days
Seroma
Time frame: 1 month
Freedom from hernia-related reinterventions
Time frame: 12 months
Late complications
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2015.
- Derived from this study: PubMed 28438090Wen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Van der Speeten, MD, PhD principal investigator
Ziekenhuis Oost-Limburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventral Hernia, run by be Medical at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate at 12 months determined by clinical examination (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01816867, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2015.