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| Name | Class |
|---|---|
| VERTICAL | UNKNOWN |
| EVAMED | OTHER |
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To evaluate the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up.
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 2 piece appliance for stomy | Device | Use of the Flexima®/Softima® 3S during 6 months following the patient's usually frequency of appliance change |
| Measure | Description | Time Frame |
|---|---|---|
| evaluation of the satisfaction of patients of the Flexima®/Softima® 3S with 6 months follow-up | The primary variable is to evaluate the degree of satisfaction of patients in terms of leakage prevention, comfort and patient's feeling of security to the Flexima®/Softima® 3S. For each item, the patient will evaluated the product thanks to a 4 points scale question (very good (4)/good(3)/ poor(2)/ very poor(1)) | the questions will be asked to the patient at each follow up visits (= at 1 month, 3 months and 6 months).Total Score will range from 3 to 12. A total score of 9 or more will define appropriate overall satisfaction. |
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Inclusion Criteria:
Exclusion Criteria:
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Patient with a Enterostomy or an urostomy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ghislaine Martin | Contact | 141107563 | +33 | ghislaine.martin@bbraun.com |
| Bénédicte Colomb | Contact | 141107574 | +33 | benedicte.colomb@bbraun.com |
| Name | Affiliation | Role |
|---|---|---|
| Danièle Chaumier | Hopital Tenon, Paris, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Lapeyronie | Recruiting | Montpellier | 34000 | France |
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| Hopital Tenon | Not yet recruiting | Paris | Île-de-France Region | 75020 | France |
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