Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.

1st SurgiConcept99 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ptosis Ptosis, Mild

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (3)

Hôpital Henri Mondor

Créteil, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

Hôpital Pierre Paul Riquet

Toulouse, France

NOT_YET_RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: At 12 months

Secondary Outcomes

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.

Time frame: Day 0 to Year 5.

Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)

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.

Time frame: 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.

Time frame: Day 0 to Year 5.

Age of face

The age of patient face will be assessed a specific question at each visit.

Time frame: Day 0 to year 5.

Safety of SPRING THREAD® Elastic Tensor Thread

All adverse event will be assessed for the study duration.

Time frame: Day 0 to month 12.

Central Contacts

Dominique MALARD

CONTACT

+33 (0)320 23 41 96 dom@springthread.com

Data from ClinicalTrials.gov

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