Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis. (ESTES)
SPRING THREAD® Elastic Tensor Thread의 성능 및 안전성에 대한 장기 평가.
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.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 장소
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Créteil, 프랑스
- Hôpital Henri Mondor
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Toulouse, 프랑스, 31000
- Hôpital Pierre Paul Riquet
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: OTHER
- 시간 관점: PROSPECTIVE
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Investigator Global Aesthetic Improvement Scale (IGAIS)
기간: At 12 months
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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
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)
기간: Day 0 to Year 5.
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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.
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Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)
기간: Day 0 to month 24
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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
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Improvement of overall facial appearance
기간: Day 0 to Year 5.
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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.
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Age of face
기간: Day 0 to year 5.
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The age of patient face will be assessed a specific question at each visit. |
Day 0 to year 5.
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Safety of SPRING THREAD® Elastic Tensor Thread
기간: Day 0 to month 12.
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All adverse event will be assessed for the study duration. |
Day 0 to month 12.
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공동 작업자 및 조사자
스폰서
협력자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .