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| Name | Class |
|---|---|
| EVAMED | OTHER |
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The purpose of this post-market clinical follow up study is to assess the safety and effectiveness of the SPRING THREAD® elastic tensor thread. The study will evaluate the outcome of the SPRING THREAD® elastic tensor thread range over a period of 5 years.
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| Measure | Description | Time Frame |
|---|---|---|
| Investigator Global Aesthetic Improvement Scale (IGAIS) | Proportion of patients with an IGAIS score between 1 and 3 showing an improvement of ptosis. This item is scaled from 1 to 5, 5 being the worst value. | At 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale) | The patient satisfaction with SGAIS score will be assessed at each visit. This item is scaled from 1 to 5, 5 being the worst value. | Day 0 to Year 5. |
| Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale) |
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Inclusion Criteria:
Exclusion Criteria:
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Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dominique MALARD | Contact | +33 (0)320 23 41 96 | dom@springthread.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Henri Mondor | Recruiting | Créteil | France |
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| ID | Term |
|---|---|
| D001763 | Blepharoptosis |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D005141 | Eyelid Diseases |
| D005128 | Eye Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
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The surgeon satisfaction with the IGAIS score will be assessed from intervention (day 0) to 12 months. This item is scaled from 1 to 5, 5 being the worst value. |
| Day 0 to month 24 |
| Improvement of overall facial appearance | The improvement of overall facial appearance (harmony) will be assessed using a 5-point patient satisfaction scale. The worst value is very unsatisfied and the highest value is very satisfied. | Day 0 to Year 5. |
| Age of face | The age of patient face will be assessed a specific question at each visit. | Day 0 to year 5. |
| Safety of SPRING THREAD® Elastic Tensor Thread | All adverse event will be assessed for the study duration. | Day 0 to month 12. |
| Hôpital Henri Mondor | Recruiting | Créteil | France |
|
| Hôpital Pierre Paul Riquet | Not yet recruiting | Toulouse | 31000 | France |
|
| D009370 |
| Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |