Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age35-75
Sponsor1st SurgiConcept
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
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 5.2
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 243
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 5.4
Age of face
The age of patient face will be assessed a specific question at each visit.
Time frame
Day 0 to year 5.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
1st SurgiConcept
Lead sponsor
EVAMED
Collaborator
Source ClinicalTrials.gov