An interventional study of Focus Group in Vascular Malformations, sponsored by University Hospital, Toulouse. Status unknown at 3 sites in France. Open to participants aged 11 Years to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-05.
Sponsored by University Hospital, Toulouse · Not applicable, Interventional, and Other
Among 12 studies in Vascular Malformations with a site in France — 5 open to participants now, 5 under way, 1 of them phase 3. Vascular Malformations · France.
Among the 12 studies in Vascular Malformations with a site in France, this one is one of 3 that started in 2018, is one of 3 with no phase, and was the 5th registered.
79 studies on the registry are indexed under Vascular Malformations; 33 are open to participants now.
This study's planned enrollment of 300 is above the median of 55 across 49 interventional studies indexed under Vascular Malformations.
Browse Vascular Malformations studies →5 of the 12 studies in Vascular Malformations with a site in France are open now, in 12 countries. Each count lists the studies.
Of the 22 Vascular Malformations studies recruiting now, 13 (59%) set no upper age limit and 7 (32%) stop at 75 or younger; 15 take children under 18; 3 take healthy volunteers.
This study: 11 Years to 15 Years · all sexes · healthy volunteers too.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2013; this study’s year is marked. 3 started in 2018.
Median enrollment 250 across the 7 interventional studies, 328 across the 5 observational. Of the 6 that completed or were terminated, 0 (0%) have results posted.
2 of 12 have an industry lead sponsor. The 10 most frequent:
University Hospital, Toulouse is the lead sponsor of 807 studies on the registry; 209 are open to participants now.
University Hospital, Toulouse has 1 study filed under Vascular Malformations — fewer than ten, so there is no comparison to draw.
1 of the studies in Vascular Malformations with a site in France that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04194619Hospices Civils de LyonPregnancy in Women With Rare Multisystemic Vascular Diseases: COGRare5 Study | 2027-02 |
Among the 12 studies in Vascular Malformations with a site in France, from their registry updates:
The low-flow malformations include venous and lymphatic malformations. The malformation often affects the skin and can extend deep to the muscles and bone, as well as to deep organs. Children with low-flow vascular malformation and their family have difficulty living with their illness and have an impact on their life quality.
In this context, the aim of the study is to develope life quality test for the children between 11 to 15 years old.
The low-flow vascular malformations include venous and lymphatic malformations. These malformations are made of dilated dysplastic vessels in which the circulation is lowed down, which can lead to phenomena of thrombosis, hemorrhage, with sometimes a repercussion on the general coagulation. The malformation often affects the skin and can extend deep to the muscles and bone, as well as to deep organs. It presents by swelling sometimes voluminous and often painful. Children with low-flow malformations and their families have difficulty living with their illness and have an impact on their quality of life (QOL).
These difficulties seem relative to :
The aim of the study is to develope a specific life quality test for children between 11 to 15 years old.
These data will be used in a second time to build and validate a scale of quality of life specific slow-flow malformations of the child aged 11 to 15 years old. The study is build in 3 parts:
Focus group: collect the dimension of the lived experience and the perceptions of the children with slow-flow malformations as well as their needs and their expectations
Validation of the life quality test: the data obtained during focus group will be used to develop the scale of life quality specific to the child aged 11 to 15 years suffering to low-flow malformations. In a second time to validate the scale, this life quality test will be send to patients.
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.
Phase 1:
Phase 2 :
Exclusion criteria :
For both phases: Pregnant or lactating women or girls,
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.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Phase 1: Collect of experiences, perceptions, difficulties, needs and expectations of patients with slow-flow vascular malformation (for the age group of 11 to 15 years-old) using the focus group method. Phase 2 : Administration of the scale of life's quality for validation.
Behavioral: Focus Group
First (phase 1), collect experiences, perceptions, difficulties, needs and expectations of patients with slow-flow malformations (for the age group of 11 to 15 years-old), carried out with 3 categories of participants and then (phase 2) development and validation of the specific scale of life's quality of slow-flow vascular malformation in children aged 11 to 15 years-old.
Specific scale of life's quality for slow-flow vascular malformation
Specific scale of life's quality for slow-flow vascular malformation. * the preliminary version of which is created by transforming the qualitative categories resulting from the qualitative analysis of the verbatim into an exhaustive list of thematic items which will then be selected and sorted by the experts * and whose final version is obtained by the statistical validation analysis aimed at structural validity and unidimensionality and convergent and discriminant validity.
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
Started Feb 2018 (actual). Primary completion is estimated for Feb 2019, 12 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.
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