Umbilical HerniasNCT01183325
Prospective Evaluation of the Proceed Ventral Patch With and Without Laparoscopic Evaluation
A study testing Proceed Ventral Patch placement in people with Umbilical Hernias and Ventral Hernias, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues. About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernias, Ventral Hernias
- What is being tested?
- Proceed Ventral Patch placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesBelgium
- Study dates
- Sep 2009to Sep 2013
- Phase
- Interventional
- 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
Who may be able to join
- Adult patient
- Written informed consent
- Umbilical, primary ventral hernias smaller than 3cm diameter
Who cannot join
- Hernias larger than 3cm
- Recurrence
- Children
- Emergency cases
- Incisional hernias
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up
For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues.
About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).
With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.
The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.
- Conditions
- Umbilical Hernias, Ventral Hernias
- Being tested
- Proceed Ventral Patch placement
- Keywords
- Umbilical and small ventral hernias less than 3cm diameter
- Medical subject headings
- Hernia, Umbilical, Hernia, Ventral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proceed Ventral Patch placementDevice
Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
| Study group | Role | What they receive |
|---|---|---|
| Proceed Ventral Patch placement | Experimental | Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control Receives: Device: Proceed Ventral Patch placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of adequately placed patches
Measured: At T 0 days
Secondary outcomes (7)
Perioperative morbidity rate
Measured: Within 30 days
Pre- and postoperative pain
Measured: At T 0 day, T 30 days and T 1 year
Number of patients needed a repositioning of the patch
Measured: At T 0 days
Reasons for inadequate positioning
Measured: At T 0 days
Number of repositioning necessary
Measured: At T 0 days
Complication ratio
Measured: At 1 year
Recurrence rate at 1 year
Measured: At 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startSep 2009
- Primary completionApr 2011
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical HerniasStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01183325
- Sponsor's protocol ID
- 2009/291
- Status last verified
- Dec 2014
- First submitted
- 12 Aug 2010
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Evaluation of the Proceed Ventral Patch for Umbilical and Small Primary Ventral Hernias Less Than 3cm Diameter With One Year Follow-up
- ClinicalTrials.gov ID
- NCT01183325
- Acronym / sponsor ID
- 2009/291
- Conditions
- Umbilical Hernias, Ventral Hernias
- Keywords
- Umbilical and small ventral hernias less than 3cm diameter
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Sep 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 17 Aug 2010 (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.
For small (2-3cm) ventral and umbilical hernias the discussion for primary suture repair or the use of mesh continues.
About 5 years ago the Ventralex patch was introduced, which combines a layer of PTFE mesh with a small polypropylene mesh and includes a circular memory ring. Despite the elegance of using this patch, recent experience showed several drawbacks both in design and efficacy (3).
With the recent development of the Proceed Ventral Patch (PVP), new elements have been introduced to overcome some of these issues.
The aim of this study is to evaluate the efficacy of clinical placement of the PVP in the intra-abdominal position in the treatment of small ventral hernias.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proceed Ventral Patch placement | Experimental | Device: Proceed Ventral Patch placementPlacement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patient
- Written informed consent
- Umbilical, primary ventral hernias smaller than 3cm diameter
Key exclusion criteria (5 listed)
- Hernias larger than 3cm
- Recurrence
- Children
- Emergency cases
- Incisional hernias
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 |
|---|---|---|
| Proceed Ventral Patch placementPlacement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control | Device | Proceed Ventral Patch placement |
Primary outcome
Percentage of adequately placed patches
Time frame: At T 0 days
7 secondary outcomes
Perioperative morbidity rate
Time frame: Within 30 days
Pre- and postoperative pain
Time frame: At T 0 day, T 30 days and T 1 year
Number of patients needed a repositioning of the patch
Time frame: At T 0 days
Reasons for inadequate positioning
Time frame: At T 0 days
Number of repositioning necessary
Time frame: At T 0 days
Complication ratio
Time frame: At 1 year
Recurrence rate at 1 year
Time frame: At 1 year
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 5 Dec 2014.
- Website of University Hospital GhentLink provided by the sponsor.
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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.
Frederik Berrevoet, MD principal investigator
University Hospital, Ghent
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Proceed Ventral Patch placement in people with Umbilical Hernias and Ventral Hernias, run by University Hospital, Ghent at 2 sites 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 5 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 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Percentage of adequately placed patches (time frame: At T 0 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Dec 2014; AzTrials last refreshed its copy on 30 Oct 2026.