Clinical trial · Observational
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients with Mild to Moderate Facial Ptosis.
Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.
NCT05746078CI-TRIAL-00083657ESTESrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ptosis | — | UNRESOLVED | — |
| Ptosis, Mild | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Investigator Global Aesthetic Improvement Scale (IGAIS)
- timeFrame
- At 12 months
- description
- 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 (5)
- measure
- Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)
- timeFrame
- Day 0 to Year 5.
- description
- 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.
- measure
- Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)
- timeFrame
- Day 0 to month 24
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.