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

Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05746078

Acronym

ESTES

Enrollment

Registered

2023-02-27

Start date

2023-02-16

Completion date

2029-03-31

Last updated

2024-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ptosis, Ptosis, Mild

Keywords

Ptosis, Moderate

Brief summary

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

35 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Investigator Global Aesthetic Improvement Scale (IGAIS)	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.

Secondary

Measure	Time frame	Description
Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)	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.
Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)	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.
Improvement of overall facial appearance	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.
Age of face	Day 0 to year 5.	The age of patient face will be assessed a specific question at each visit.
Safety of SPRING THREAD® Elastic Tensor Thread	Day 0 to month 12.	All adverse event will be assessed for the study duration.

Countries

France

Contacts

Primary ContactDominique MALARD

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

Outcome results