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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A02819-38 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| EVAMED | OTHER |
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The purpose of this post-market clinical follow-up is to assess the safety and performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face. The study will assess the safety result up to 5 years after the intervention.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insertion/placement of tension threads | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess medical device safety at 5 years after intervention. | The rate of sequelae and complications related to the device or procedure within 5 years after the intervention | at 5 years follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by the subject (overall and by area) | Completion of effectiveness score by patient (GAIS) (overall and by area). It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse. | At 3-months, 1,2,3,4 and 5 years follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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Subject aged 18 years old or more who need of facial tissue enhancement.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Vincent FOUMENTEZE | Contact | +32 (0) 468 38 72 97 | foumentezevincent@threadandlift.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Evamed/1Med | Recruiting | Hérouville-Saint-Clair | 14200 | France |
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| ID | Term |
|---|---|
| D019066 | Facies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016254 | Mutagenesis, Insertional |
| ID | Term |
|---|---|
| D015202 | Protein Engineering |
| D005818 | Genetic Engineering |
| D005821 | Genetic Techniques |
| D008919 | Investigative Techniques |
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| To assess the effectiveness of the Infinite-Thread® permanent tension thread by the physician (overall and by area) | Completion of effectiveness score by physician (GAIS) (overall and by area). It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse. | At 3-months, 1,2,3,4 and 5 years follow-up |
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the physician. | Physician effectiveness scale (5-point ordinal scales) by area. Values range from 0 to 4. 0 is the minimum value and the best (Non-sagging or non-marked area). 4 is the maximum and the worse value (Area that is significantly sagging or marked). | At 3 months, 1, 2, 3, 4, and 5 years follow-up |
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by the independant assessor (physician) (overall and by area). | Completion of effectiveness score by independant assessor (physician) (GAIS) (overall and by area). Blind analysis of picture. It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse. | At 3-months, 1,2,3,4 and 5 years follow-up |
| To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the independent assessor (physician). | Independent assessor (physican) effectiveness scale (5-point ordinal scales) by area. Blind analysis of picture. Values range from 0 to 4. 0 is the minimum value and the best (Non-sagging or non-marked area). 4 is the maximum and the worse value (Area that is significantly sagging or marked). | At 3 months, 1, 2, 3, 4, and 5 years follow-up |
| D009154 |
| Mutation |
| D014644 | Genetic Variation |
| D055614 | Genetic Phenomena |
| D016296 | Mutagenesis |