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.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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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

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

Other trials in France

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 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.

Conditions: Abdominal Wall Defect, Abdominal Wall Injury, Abdominal Hernia
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.

4 Nov 2020Oct 2026

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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