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

Recruiting

• Conditions: Ptosis; Ptosis, Mild

• Registration Number: NCT05746078
• Lead Sponsor: 1st SurgiConcept

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-16
• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-02-17
• Study First Posted: 2023-02-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-09
• Last Update Posted: 2024-12-12
• Primary Completion: 2025-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 99

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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.

Trial Locations

Locations (2)

Hôpital Henri Mondor; 🇫🇷 Créteil, France

Hôpital Pierre Paul Riquet; 🇫🇷 Toulouse, France