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

1st SurgiConcept2 sites in 1 country99 target enrollmentFebruary 16, 2023

ConditionsPtosis Ptosis, Mild

Overview

Phase: N/A
Intervention: Not specified
Conditions: Ptosis
Sponsor: 1st SurgiConcept
Enrollment: 99
Locations: 2
Primary Endpoint: Investigator Global Aesthetic Improvement Scale (IGAIS)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 16, 2023

End Date

March 2029

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

1st SurgiConcept

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

Improvement of overall facial appearance(Day 0 to Year 5.)
Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)(Day 0 to Year 5.)
Age of face(Day 0 to year 5.)
Safety of SPRING THREAD® Elastic Tensor Thread(Day 0 to month 12.)
Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)(Day 0 to month 24)