Safety and Clinical Performance of a Biological Matrix Used in Abdominal Wall Reconstruction

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

92 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-04

Study Completion Date

2026-11-30

Brief Summary

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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.

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Detailed Description

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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

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Abdominal Wall Defect Abdominal Wall Injury Abdominal Hernia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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CELLIS (Porcine Acellular Dermal Matrix, PADM)

Biological membrane used in abdominal reconstruction

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No