Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis. (ESTES)
SPRING THREAD® Elastic Tensor Thread の性能と安全性の長期評価。
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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究場所
-
-
-
Créteil、フランス
- Hôpital Henri Mondor
-
Toulouse、フランス、31000
- Hôpital Pierre Paul Riquet
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.
説明
Inclusion Criteria:
- Men / women aged 35 to 75 with facial ptosis (cheekbones, jowls) with or without a history of aesthetic treatment (botox, filler, surgical lift).
- Patient able to understand the explanations given.
- Patient informed and not objecting to participate in the study.
- Patient able to comply with protocol requirements, including follow-up visits.
- Patient affiliated to social security.
Exclusion Criteria:
- Patient unable to understand study information and attend study visits.
- Patient did not give consent to participate.
- Patients who have had a previous facial rejuvenation treatment in the 3 months prior to the study.
- Patients treated with long-term systemic corticosteroids.
- Patients with visceral failure, chronic immunological pathology, pregnant or breasfeading women.
- Patient participating or having participated in another clinical trial protocol, drug or medical device within 30 days of inclusion.
- Patient refusing to participate in the clinical investigation.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：OTHER
- 時間の展望：PROSPECTIVE
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Investigator Global Aesthetic Improvement Scale (IGAIS)
時間枠：At 12 months
|
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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)
時間枠：Day 0 to Year 5.
|
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)
時間枠：Day 0 to month 24
|
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
時間枠：Day 0 to Year 5.
|
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
時間枠：Day 0 to year 5.
|
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
時間枠：Day 0 to month 12.
|
All adverse event will be assessed for the study duration. |
Day 0 to month 12.
|
協力者と研究者
スポンサー
協力者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。