Actively Recruiting
Long-term Assessment of the Performance and Safety of SPRING THREAD42 Elastic Tensor Thread
Led by 1st SurgiConcept · Updated on 2024-12-12
99
Participants Needed
3
Research Sites
208 weeks
Total Duration
On this page
Sponsors
1
1st SurgiConcept
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of the SPRING THREAD42 elastic tensor thread in adults aged 35 to 75 years with mild to moderate facial ptosis, which affects areas like the cheekbones and jowls. This observational study is sponsored by 1st SurgiConcept and aims to follow outcomes over a period of 5 years to better understand the product's performance after market release. The study tracks the use of SPRING THREAD42 elastic tensor thread without additional interventions or comparison groups. Participants receive treatment and are monitored for changes in facial aesthetic appearance. The primary measure is the Investigator Global Aesthetic Improvement Scale (IGAIS) assessed at 12 months. Additional evaluations include patient and surgeon satisfaction scores, improvements in overall facial appearance and perceived facial age, and safety assessments during the first year. Participants will attend scheduled follow-up visits over five years to monitor their progress and record satisfaction and safety data. Assessments include aesthetic improvement ratings by investigators and patients, with regular tracking of facial appearance and safety events. The study ensures ongoing observation of thread performance and participant well-being throughout the long-term follow-up period ending in March 2029.
CONDITIONS
Brief Title
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men or women aged 35 to 75 years with facial ptosis involving cheekbones or jowls, with or without prior aesthetic treatments like botox, filler, or surgical lift
- Ability to understand study explanations
- Informed consent given and no objection to participate
- Ability to follow protocol requirements including attending follow-up visits
- Affiliated to social security
You will not qualify if you...
- Unable to understand study information or attend study visits
- No consent given to participate
- Facial rejuvenation treatment within 3 months before the study
- Treatment with long-term systemic corticosteroids
- Presence of visceral failure, chronic immune disease, or pregnancy/breastfeeding
- Participation in another clinical trial within 30 days before inclusion
- Refusal to participate in the clinical investigation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants are observed over time to assess the performance and safety of the SPRING THREAD® Elastic Tensor Thread.
Visits at Day 0 and follow-up visits up to 5 years
Trial Site Locations
Total: 3 locations
1
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
2
Hôpital Henri Mondor
Créteil, France
Actively Recruiting
3
Hôpital Pierre Paul Riquet
Toulouse, France, 31000
Not Yet Recruiting
Research Team
D
Dominique MALARD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here