Congenital Diaphragmatic Repair Clinical Trial
Official title:
Mecanical Properties of Biomaterials and Biological Integration of Diaphragmatic Prothesis in Infancy
| NCT number | NCT03316924 |
| Other study ID # | 6834 |
| Secondary ID | |
| Status | Completed |
| Phase | |
| First received | |
| Last updated | |
| Start date | May 29, 2018 |
| Est. completion date | May 31, 2023 |
| Verified date | July 2021 |
| Source | University Hospital, Strasbourg, France |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
In case of CDH, the incomplete development of a part of the diaphragm allows abdominal viscera to herniate into thorax cavity during fetal development and impaired lung and heart development. After birth, CDH patients who survived thanks to an active reanimation management undergo diaphragmatic repair. In case of large defect, a patch is needed to complete diaphragmatic closure. Thanks to primary cell culture from foreskin, peritoneal epithelium or cremaster dedicated to incineration investigators want to analyse biological integration of actually used prothesis and others innovations.
| Status | Completed |
| Enrollment | 1 |
| Est. completion date | May 31, 2023 |
| Est. primary completion date | May 29, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 0 Years to 14 Years |
| Eligibility | Inclusion Criteria: - Minor aged 0 (day of birth) to 14 years - Patient for whom an indication of posthectomy and / or cure of inguinal hernia and / or testicular ectopy is retained - Patient whose legal representatives have agreed to the use of operational waste from mesenchymal tissues (foreskin, cremaster and peritoneum) destined for incineration. - Patient affiliated to a social security scheme Exclusion Criteria: - parents don't agree to the use of its operating waste for research purposes |
| Country | Name | City | State |
|---|---|---|---|
| France | Les Hôpitaux Universitaires de Strasbourg | Strasbourg |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Strasbourg, France |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | cell colonization | Study cell colonization | samples are processed immediately after sampling | |
| Primary | quality of the extracellular matrix | Quality of the extracellular matrix produced in vitro in contact with the currently used implant materials compared to biomaterials under development | samples are processed immediately after sampling |