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Active, not recruitingNCT05746078ESTESUpdated Sep 30, 2026

Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis.

An observational study in Ptosis and Ptosis, Mild, sponsored by 1st SurgiConcept. Active, not recruiting at 2 sites in France. Open to participants aged 35 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by 1st SurgiConcept · Observational

Updated Sep 30, 2026Now Active, not recruitingPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
99
Ages
35 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ptosis
  • Ptosis, Mild

Keywords

  • Ptosis, Moderate
03

In context

Blepharoptosis

75 studies on the registry are indexed under Blepharoptosis; 14 are open to participants now.

This study's planned enrollment of 99 is above the median of 57 across 16 observational studies indexed under Blepharoptosis.

Browse Blepharoptosis studies →

Lead sponsor

This is the only study on the registry with 1st SurgiConcept as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 .
  • 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
99 participants (estimated)
Patient registry
No
06

What researchers measure

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 months

Secondary 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 24

  3. 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.

  5. Safety of SPRING THREAD® Elastic Tensor Thread

    All adverse event will be assessed for the study duration.

    Time frame: Day 0 to month 12.

07

Study locations

2 sites
08

Updates

1 registry update since Sep 25, 2026
Status
Recruiting→Active, not recruiting
changed Sep 30, 2026
Sites
1 site removed
Show 1 removed
  • Hôpital Henri Mondor · Créteil, France
Sep 30, 2026
Primary completion
Mar 2025→Feb 7, 2026 (actual)
Sep 30, 2026
Study completion
Mar 2029→Dec 2030
Sep 30, 2026
Show all 1 update
  1. Sep 30, 2026
    Recruiting→Active, not recruiting
    1 site removed
    Show 1 removed
    • Hôpital Henri Mondor · Créteil, France
    Primary completion Mar 2025→Feb 7, 2026 (now actual)
    Study completion Mar 2029→Dec 2030
    + 5 other changes: index terms, identifiers, verification date, oversight details and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT05746078
Lead sponsor
1st SurgiConcept
Collaborators
EVAMED
Responsible party
Sponsor
First posted
Feb 27, 2023
Start date
Feb 16, 2023
Primary completion
Feb 7, 2026
Completion
Dec 2030 (estimated)
Last update
Sep 30, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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