Abdominal Wall DefectPMCF_AWRNCT04580511
Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction
An observational study of Abdominal Wall Defect and Abdominal Wall Injury, run by Meccellis Biotech at 4 sites in France.
Trial summary
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Wall Defect, Abdominal Wall Injury, Abdominal Hernia
- What is being tested?
- CELLIS (Porcine Acellular Dermal Matrix, PADM)
- Type of treatment
- Medical device
- How many people
- 92 participants
- Where
- 4 sitesFrance
- Study dates
- 4 Nov 2020to Oct 2026
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.
Who may be able to join
- Patient aged ≥18 years,
- Patient with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure,
- Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
- Patient being informed of the porcine origin of the device in advance of the procedure.
Who cannot join
- Patient with known hypersensitivity to porcine materials,
- Patient who is pregnant,
- Patient having refused to participate to the study,
- Patient refusing to return for the follow-up visits.
Trial locations and contacts
4 sites in 1 country.
France4 sites
CHU Caen Normandie, Service de Chirurgie Digestive
Caen
Groupe Hospitalier La Rochelle - Ré - Aunis
La Rochelle
CHU Montpellier, Hôpital Saint-Eloi, Pôle digestif, Service de Chirurgie Digestive B et Transplantation
Montpellier
CHU Nantes Hôtel Dieu
Nantes, 44093
About this study
Official title: Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.
The general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material.
The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
Read the detailed description
The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 3 investigational centres including 112 patients scheduled for an abdominal wall reconstruction.
Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.
Patients will return for ambulatory visits on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.
CELLIS will be implanted by open technique following standard techniques. The membrane can be used in bridged or reinforced repairs. Mesh placement can include inlay (bridging), underlay intraperitoneal, sublay (retrorectus/retromuscular) positions.
- Being tested
- CELLIS (Porcine Acellular Dermal Matrix, PADM)
- Keywords
- abdominal wall reconstruction, biological mesh
- Medical subject headings
- Hernia, Abdominal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CELLIS (Porcine Acellular Dermal Matrix, PADM)Device
Biological membrane used in abdominal reconstruction
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of adverse events including reoperation and removal of the mesh. The main complications of interest are Surgical Site Occurrence (SSO) including Surgical Site Infection (SSI).
Percentage
Measured: From the surgical procedure throughout the entire 24-month follow-up period
Secondary outcomes (4)
Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan
Percentage
Measured: Throughout the study until end of the 24-month follow-up period
Rate of recurrence/incisional hernia requiring reoperation
Percentage
Measured: Throughout the study until end of the 24-month follow-up period
Rate of abdominal wall laxity
Percentage
Measured: Throughout the study until end of the 24-month follow-up period
Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.
Summarized and listed
Measured: During the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start4 Nov 2020
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Wall DefectStudies 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
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meccellis Biotech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hassan BOUYABRINE, MD, Principal investigator, CHU Montpellier, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04580511
- Sponsor's protocol ID
- AWR_01_CIP
- Acronym
- PMCF_AWR
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2020
- Last updated
- 8 Oct 2026
- 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 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Clinical Performance of a Non-cross-linked Porcine Acellular Dermal Matrix Used in Abdominal Wall Reconstruction: an Observational Prospective Study.
- ClinicalTrials.gov ID
- NCT04580511
- Acronym / sponsor ID
- PMCF_AWR / AWR_01_CIP
- Keywords
- abdominal wall reconstruction, biological mesh
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Meccellis BiotechIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2020 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 8 Oct 2020 (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 general objective of the study is to confirm the medium/long-term safety and clinical performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure, and to identify emerging risks in comparison to the clinical data related to other types of fixation material.
The present study will be a prospective multicentric non-randomized and noncontrolled trial involving 112 patients followed for 24 months. The study will be conducted in France in 3 investigational centres.
Detailed description
The study will be prospective, multicentric, single-arm, observational (non-interventional) to evaluate the safety and performance of the CELLIS membrane used in abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.
All evaluations will be performed and products used according to the usual practice, without additional or unusual diagnostic, treatment and monitoring procedure.
The study will be conducted in France in 3 investigational centres including 112 patients scheduled for an abdominal wall reconstruction.
Each patient will participate in one assessment period including a preoperative visit, followed by the day of surgical procedure and a hospitalization period.
Patients will return for ambulatory visits on day 30 (+/- 7 days), on month 3 (+/- 2 weeks), on month 12 (+/- 2 weeks) and on month 24 (+/-2 weeks) post-surgery.
CELLIS will be implanted by open technique following standard techniques. The membrane can be used in bridged or reinforced repairs. Mesh placement can include inlay (bridging), underlay intraperitoneal, sublay (retrorectus/retromuscular) positions.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.
Key inclusion criteria (4 listed)
- Patient aged ≥18 years,
- Patient with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure,
- Patient being informed of its participation to the study and of the follow-up visits, and having no objection to the clinical data collection and medical file access,
- Patient being informed of the porcine origin of the device in advance of the procedure.
Key exclusion criteria (4 listed)
- Patient with known hypersensitivity to porcine materials,
- Patient who is pregnant,
- Patient having refused to participate to the study,
- Patient refusing to return for the follow-up visits.
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 |
|---|---|---|
| CELLIS (Porcine Acellular Dermal Matrix, PADM)Biological membrane used in abdominal reconstruction | Device | – |
Primary outcome
Rate of adverse events including reoperation and removal of the mesh. The main complications of interest are Surgical Site Occurrence (SSO) including Surgical Site Infection (SSI).
Time frame: From the surgical procedure throughout the entire 24-month follow-up period
Percentage
4 secondary outcomes
Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan
Time frame: Throughout the study until end of the 24-month follow-up period
Rate of recurrence/incisional hernia requiring reoperation
Time frame: Throughout the study until end of the 24-month follow-up period
Rate of abdominal wall laxity
Time frame: Throughout the study until end of the 24-month follow-up period
Description of device deficiency: inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety or performance. Device deficiencies include malfunctions, use errors, and inadequate labelling.
Time frame: During the surgical procedure
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 8 Oct 2026.
- 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.
Hassan BOUYABRINE, MD principal investigator
CHU Montpellier, France
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Wall Defect and Abdominal Wall Injury, run by Meccellis Biotech at 4 sites in France.
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 4 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 8 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
Rate of adverse events including reoperation and removal of the mesh. The main complications of interest are Surgical Site Occurrence (SSO) including Surgical Site Infection (SSI). (time frame: From the surgical procedure throughout the entire 24-month follow-up period). 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 8 Oct 2026.