Inguinal HerniaNCT01193985
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
A study testing TIGR Matrix Surgical Mesh in people with Inguinal Hernia, run by Novus Scientific at 2 sites in Sweden.
Trial summary
This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia. The primary objective is to determine the safety of the WK-6 surgical mesh. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- TIGR Matrix Surgical Mesh
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesSweden
- Study dates
- Apr 2009to Mar 2011
- 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
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who have given informed consent
- Male, 18 years and older.
- Patients with primary unilateral inguinal hernia
- Planned surgery procedure according to Lichtenstein technique
Who cannot join
- Patients who are unwilling and/or unable to give informed consent
- Hernia strangulated or irreducible
- Recurrent Hernia
- Previous mesh surgery on the same side
- Class >IIa patients
- Unable to walk 500 meters
Show all 22Show fewer
- BMI >30 kg/m2
- Warfarin treatment, ongoing or within two weeks of surgery.
- Peripheral artery disease
- Chronic back pain, as judged by the investigator.
- Hip joint arthrosis
- Hypermobility syndrome, as judged by the investigator.
- Constipation
- Drug or alcohol abuse
- COPD (chronic obstructive pulmonary disease)
- Patients at increased risk of death from a pre-existing concurrent illness
- Patients participating in another clinical study
- Patients who have used any other investigational drug or device within 1 month
- Patients who cannot communicate reliably with the investigator
- Patients who are unlikely to cooperate with the requirements of the study
- Patients who are employees at the investigational site; relatives or spouse of the PI.
- Patients not suitable based upon investigator decision
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Sahlgrenska University Hospital
Gothenburg
Kungsbacka Hospital
Kungsbacka
About this study
This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.
The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be compared retrospectively with published studies on inguinal hernia mesh.
The secondary objectives are to explore the performance of the surgical mesh by measuring the pain pre and post surgery as well as a number of relevant variables for establishing the performance of the mesh. Data will be compared retrospectively with previous studies on inguinal hernia mesh with a follow-up of at least one year.
- Conditions
- Inguinal Hernia
- Being tested
- TIGR Matrix Surgical Mesh
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIGR Matrix Surgical MeshDevice
Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Device: TIGR Matrix Surgical Mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events or Serious Adverse Events
Safety is assessed by monitoring the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related and unrelated to the mesh and rehabilitation. AEs and SAEs will be collected during surgery and throughout the follow up period. Possible adverse reactions with the use of any prosthesis may include but are not limited to infection, inflammation, extrusion, dhesion, fistula formation, seroma formation, hematoma, and recurrence of the hernia or tissue defect.
Measured: 12 months
Secondary outcomes (1)
Pain
The experienced pain will be measured by an ungraded Visual Analogue Scale (VAS). VAS will be assessed before the surgery and during the follow up period and elucidate the pain experienced during different conditions. A symptoms questionnaire and an analgesics diary will be used to assess the performance of the WK-6 surgical mesh for use in inguinal hernia repair.
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 posted2 Sep 2010 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novus Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Stellan Björck, MD, PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01193985
- Sponsor's protocol ID
- NS-WK-6
- Status last verified
- Apr 2011
- First submitted
- 1 Sep 2010
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT01193985
- Acronym / sponsor ID
- NS-WK-6
- Conditions
- Inguinal Hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Novus ScientificIndustry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 2 Sep 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.
This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.
The primary objective is to determine the safety of the WK-6 surgical mesh. Data will be compared retrospectively with published studies on inguinal hernia mesh.
The secondary objectives are to explore the performance of the surgical mesh by measuring the pain pre and post surgery as well as a number of relevant variables for establishing the performance of the mesh. Data will be compared retrospectively with previous studies on inguinal hernia mesh with a follow-up of at least one year.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: TIGR Matrix Surgical Mesh |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients who have given informed consent
- Male, 18 years and older.
- Patients with primary unilateral inguinal hernia
- Planned surgery procedure according to Lichtenstein technique
Key exclusion criteria (22 listed)
- Patients who are unwilling and/or unable to give informed consent
- Hernia strangulated or irreducible
- Recurrent Hernia
- Previous mesh surgery on the same side
- Class >IIa patients
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 |
|---|---|---|
| TIGR Matrix Surgical MeshLichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh | Device | Intervention |
Primary outcome
Frequency of Adverse Events or Serious Adverse Events
Time frame: 12 months
Safety is assessed by monitoring the incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) related and unrelated to the mesh and rehabilitation. AEs and SAEs will be collected during surgery and throughout the follow up period. Possible adverse reactions with the use of any prosthesis may include but are not limited to infection, inflammation, extrusion, dhesion, fistula formation, seroma formation, hematoma, and recurrence of the hernia or tissue defect.
1 secondary outcome
Pain
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 20 Apr 2011.
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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.
Stellan Björck, MD, PhD principal investigator
Sahlgrenska University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIGR Matrix Surgical Mesh in people with Inguinal Hernia, run by Novus Scientific at 2 sites in Sweden.
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 4 inclusion and 22 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 20 Apr 2011. 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 Sweden. 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?
Frequency of Adverse Events or Serious Adverse Events (time frame: 12 months). 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 20 Apr 2011; AzTrials last refreshed its copy on 6 Nov 2026.