An observational study in Abdominal Wall Defect, Abdominal Wall Injury and Abdominal Hernia, sponsored by Meccellis Biotech. Active, not recruiting at 4 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by Meccellis Biotech · Observational
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.
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.
82 studies on the registry are indexed under Hernia, Abdominal; 19 are open to participants now.
This study's enrollment of 92 is below the median of 115 across 29 observational studies indexed under Hernia, Abdominal.
Browse Hernia, Abdominal studies →Meccellis Biotech is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult with an indication of abdominal wall reconstruction including, but not limited to, ventral hernia repair and stoma closure.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological membrane used in abdominal reconstruction
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
Time frame: From the surgical procedure throughout the entire 24-month follow-up period
Rate of recurrence/incisional hernia evaluated by clinical examination and/or CT-scan
Percentage
Time frame: Throughout the study until end of the 24-month follow-up period
Rate of recurrence/incisional hernia requiring reoperation
Percentage
Time frame: Throughout the study until end of the 24-month follow-up period
Rate of abdominal wall laxity
Percentage
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.
Summarized and listed
Time frame: During the surgical procedure
Plan to share: No
No publications or documents are linked to this record.
Started Nov 2020 (actual). Primary completion is estimated for Oct 2026, 71 months after the start.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 8, 2026: primary completion Nov 2026 → Oct 2026 and completion Nov 2026 → Oct 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Meccellis Biotech