HerniaNCT06042205
TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Pilot Study
A study testing TISSIUM™ Atraumatic Hernia Repair System (TAHRS) in people with Hernia, run by Tissium at 5 sites in 2 countries.
Trial summary
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hernia
- What is being tested?
- TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 4 Jul 2023to 4 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is 18 years old or older;
- Patient willing and able to provide a signed Patient Informed Consent Form;
- Has a midline primary ventral, umbilical or incisional hernia;
- Scheduled for a laparoscopic IPOM hernia repair;
- Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect
Who cannot join
- Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
- BMI > 40;
- Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
- Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
- Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
- Patient with Type 1 or uncontrolled Type 2 Diabetes Mellitus;
- Patient has more than one hernia defect (to be confirmed intraoperatively);
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium4 sites
Imelda Hospital
Bonheiden
Ziekenhuis Oost-Limburg [ZOL]
Genk, Limburg, 3600
AZ Sint-Jan
Ruddershove
CHU UCL Namur
Yvoir, 5530
About this study
Official title: ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Atraumatic Hernia Repair System (TAHRS) for Laparoscopic Hernia Repair
The purpose of this study is to capture preliminary clinical safety and performance on the TAHRS
- Conditions
- Hernia
- Being tested
- TISSIUM™ Atraumatic Hernia Repair System (TAHRS)
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TISSIUM™ Atraumatic Hernia Repair System (TAHRS)Device
The TAHRS is intended for fixation of prosthetic material to soft tissue
| Study group | Role | What they receive |
|---|---|---|
| Hernia repair | Experimental | There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Atraumatic Hernia Repair System (TAHRS) Receives: Device: TISSIUM™ Atraumatic Hernia Repair System (TAHRS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serious Adverse Device Effect (SADEs)
Cumulative incidence of complications (CIC) related to the TAHRS including:
Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,
Measured: through 12 months post-surgery
Secondary outcomes (1)
Rate of hernia recurrence through 12 months post- surgery
Measured: through 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2023
- Study start4 Jul 2023
- Primary completion4 Jul 2026 (estimated)
- Study completion4 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tissium
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06042205
- Sponsor's protocol ID
- PF00006-CLPR-002
- Status last verified
- Jul 2025
- First submitted
- 8 Sep 2023
- Last updated
- 16 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ALPHA: A Pilot Study to Evaluate the Initial Safety and Performance of the TISSIUM™ Atraumatic Hernia Repair System (TAHRS) for Laparoscopic Hernia Repair
- ClinicalTrials.gov ID
- NCT06042205
- Acronym / sponsor ID
- PF00006-CLPR-002
- Conditions
- Hernia
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 78 participants (actual)
- Lead sponsor
- TissiumIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- 4 Jul 2026 (estimated)
- Study completion
- 4 Jul 2026 (estimated)
- First posted
- 18 Sep 2023 (actual)
- 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 this study is to capture preliminary clinical safety and performance on the TAHRS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hernia repair | Experimental | Device: TISSIUM™ Atraumatic Hernia Repair System (TAHRS)There is no comparator for this study. All patients are in the treatment allocated group for hernia repair with TISSIUM™ Atraumatic Hernia Repair System (TAHRS) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18 years old or older;
- Patient willing and able to provide a signed Patient Informed Consent Form;
- Has a midline primary ventral, umbilical or incisional hernia;
- Scheduled for a laparoscopic IPOM hernia repair;
- Hernia can be successfully repaired with at least a 5 cm overlap of the mesh on all sides of the defect
Key exclusion criteria (7 listed)
- Patient has a known or suspected hypersensitivity to the constituent polymer of the investigational device, mesh, or other surgical products (e.g., sutures);
- BMI > 40;
- Patient is a current smoker, defined as self-reporting smoking more than 1 cigarette per day;
- Patient is taking systemic immunosuppressive medications, systemic steroids, or chemotherapy at the time of informed consent;
- Patient is pregnant, plans to become pregnant during the study period, or is breastfeeding;
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 |
|---|---|---|
| TISSIUM™ Atraumatic Hernia Repair System (TAHRS)The TAHRS is intended for fixation of prosthetic material to soft tissue | Device | Hernia repair |
Primary outcome
Serious Adverse Device Effect (SADEs)
Time frame: through 12 months post-surgery
Cumulative incidence of complications (CIC) related to the TAHRS including: Infection, Chronic pain, Recurrence of hernia, Impaired/delayed healing at the surgical site(s), Allergic reaction/hypersensitivity reaction,
1 secondary outcome
Rate of hernia recurrence through 12 months post- surgery
Time frame: through 12 months post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TISSIUM™ Atraumatic Hernia Repair System (TAHRS) in people with Hernia, run by Tissium at 5 sites in 2 countries.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Spain. 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?
This study is still under way. Results are not available in the source record yet.
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?
Serious Adverse Device Effect (SADEs) (time frame: through 12 months post-surgery). 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 16 Jul 2025; AzTrials last refreshed its copy on 1 Nov 2026.