Congenital Diaphragmatic RepairNCT03316924
Analysis of in Vitro Biological Reaction of Diaphragmatic Prothesis When Congenital Diaphragmatic Hernia (CDH) Repair
An observational study of Congenital Diaphragmatic Repair, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 14 years
- Conditions the study is for
- Congenital Diaphragmatic Repair
- What is being tested?
- Foreskin resection
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- 1 siteFrance
- Study dates
- 29 May 2018to 31 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 0 to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: Children that benefits of a foreskin resection, inguinal hernia repair or orchidopexy
Who may be able to join
- 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
Who cannot join
- parents don't agree to the use of its operating waste for research purposes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mecanical Properties of Biomaterials and Biological Integration of Diaphragmatic Prothesis in Infancy
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.
- Conditions
- Congenital Diaphragmatic Repair
- Being tested
- Foreskin resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Foreskin resectionProcedure or surgery
Also called orchidopexie, inguinal hernia repair
During the pediatric surgery consultation, the doctor will decide between Foreskin resection, orchidopexie or inguinal hernia repair.
What is being measured
The primary outcome is the main question the study is designed to answer.
cell colonization
Study cell colonization
Measured: samples are processed immediately after sampling
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
Measured: samples are processed immediately after sampling
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2017
- Study start29 May 2018
- Primary completion29 May 2023
- Study completion31 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Diaphragmatic RepairStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle TALON, MD, Principal investigator, Les Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03316924
- Sponsor's protocol ID
- 6834
- Status last verified
- Jul 2021
- First submitted
- 17 Oct 2017
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mecanical Properties of Biomaterials and Biological Integration of Diaphragmatic Prothesis in Infancy
- ClinicalTrials.gov ID
- NCT03316924
- Acronym / sponsor ID
- 6834
- Conditions
- Congenital Diaphragmatic Repair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 29 May 2023 (actual)
- Study completion
- 31 May 2023 (actual)
- First posted
- 23 Oct 2017 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 0 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children that benefits of a foreskin resection, inguinal hernia repair or orchidopexy
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- parents don't agree to the use of its operating waste for research purposes
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 |
|---|---|---|
| Foreskin resectionAlso: orchidopexie, inguinal hernia repairDuring the pediatric surgery consultation, the doctor will decide between Foreskin resection, orchidopexie or inguinal hernia repair. | Procedure or surgery | – |
Primary outcome
cell colonization
Time frame: samples are processed immediately after sampling
Study cell colonization
quality of the extracellular matrix
Time frame: samples are processed immediately after sampling
Quality of the extracellular matrix produced in vitro in contact with the currently used implant materials compared to biomaterials under development
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Undecided
Related trials for Congenital Diaphragmatic Repair
Enrolling by invitation
Palliative Care Needs of Children With Rare Diseases and Their Families
Trisomy 13 Syndrome, Arthrogryposis Congenita Multiplex With Intestinal Atresia
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.
Isabelle TALON, MD principal investigator
Les Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Diaphragmatic Repair, run by University Hospital, Strasbourg, France at 1 site 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 1 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: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
cell colonization (time frame: samples are processed immediately after sampling). The study lists 2 primary outcomes in all. 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 19 Sep 2024.