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

December 9, 2024 updated by: 1st SurgiConcept

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Dominique MALARD
Phone Number: +33 (0)320 23 41 96
Email: dom@springthread.com

Study Locations

France
- - Créteil, France
    - Recruiting
    - Hopital Henri Mondor
    - Contact:
      
      Jean-Paul MENINGAUD, Pr
  - Toulouse, France, 31000
    - Not yet recruiting
    - Hôpital Pierre Paul Riquet
    - Contact:
      
      Céline DEKEISTER, Dr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Sampling Method

Non-Probability Sample

Study Population

Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Investigator Global Aesthetic Improvement Scale (IGAIS) Time Frame: 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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale) Time Frame: 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) Time Frame: 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 Time Frame: 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 Time Frame: 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 Time Frame: Day 0 to month 12.	All adverse event will be assessed for the study duration.	Day 0 to month 12.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

1st SurgiConcept

Collaborators

EVAMED

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 16, 2023

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

February 17, 2023

First Submitted That Met QC Criteria