Assessing the safety and effectiveness of SPRING THREAD® for facial ptosis
Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.
This study is testing if the SPRING THREAD® can safely help people aged 35 to 75 with mild to moderate facial drooping look better over five years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 99 (estimated) |
| Ages | 35 Years to 75 Years |
| Sex | All |
| Sponsor | 1st SurgiConcept Industry-sponsored |
| Locations | 3 sites (Créteil and 2 other locations) |
| Trial ID | NCT05746078 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the safety and effectiveness of the SPRING THREAD® elastic tensor thread in patients experiencing mild to moderate facial ptosis. Over a period of five years, the study will monitor outcomes related to the use of this innovative treatment. Participants will include men and women aged 35 to 75, with or without prior aesthetic treatments. The study will follow a structured protocol to ensure compliance and thorough assessment of results.
Who should consider this trial
Good fit: Ideal candidates are men and women aged 35 to 75 with mild to moderate facial ptosis.
Not a fit: Patients with recent facial rejuvenation treatments or those with certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a non-surgical option for improving facial appearance in patients with ptosis.
How similar studies have performed: While this approach is relatively novel, similar studies assessing non-surgical treatments for facial ptosis have shown promising results.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Créteil and 2 other locations
- Hôpital Henri Mondor — Créteil, France (Recruiting)
- Hôpital Henri Mondor — Créteil, France (Recruiting)
- Hôpital Pierre Paul Riquet — Toulouse, France (Not_yet_recruiting)
Study contacts
- Study coordinator: Dominique MALARD
- Email: dom@springthread.com
- Phone: +33 (0)320 23 41 96
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.