PtosisESTESNCT05746078
Performance and Safety Assessment of SPRING THREAD® Elastic Tensor Thread in Patients With Mild to Moderate Facial Ptosis.
An observational study of Ptosis and Ptosis, Mild, run by 1st SurgiConcept at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 75 years
- Conditions the study is for
- Ptosis, Ptosis, Mild
- How many people
- 99 participants
- Where
- 2 sitesFrance
- Study dates
- 16 Feb 2023to Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hôpital Henri Mondor
Créteil
Hôpital Pierre Paul Riquet
Toulouse, 31000
About this study
Official title: Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.
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
- Ptosis, Ptosis, Mild
- Keywords
- Ptosis, Moderate
- Medical subject headings
- Blepharoptosis, Lymphoma, Follicular
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 12 months
Secondary outcomes (5)
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.
Measured: Day 0 to Year 5.
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.
Measured: Day 0 to month 24
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.
Measured: Day 0 to Year 5.
Age of face
The age of patient face will be assessed a specific question at each visit.
Measured: Day 0 to year 5.
Safety of SPRING THREAD® Elastic Tensor Thread
All adverse event will be assessed for the study duration.
Measured: Day 0 to month 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2023
- Study start16 Feb 2023
- Primary completion7 Feb 2026
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PtosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- 1st SurgiConcept
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05746078
- Sponsor's protocol ID
- ESTES
- Acronym
- ESTES
- Status last verified
- Sep 2026
- First submitted
- 17 Feb 2023
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.
- ClinicalTrials.gov ID
- NCT05746078
- Acronym / sponsor ID
- ESTES / ESTES
- Conditions
- Ptosis, Ptosis, Mild
- Keywords
- Ptosis, Moderate
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- 1st SurgiConceptIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 16 Feb 2023 (actual)
- Primary completion
- 7 Feb 2026 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 27 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population involved are men or women aged 35 to 75 with facial ptosis (mild to moderate) eligibles for tensor thread treatment.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Investigator Global Aesthetic Improvement Scale (IGAIS)
Time frame: At 12 months
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.
5 secondary outcomes
Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)
Time frame: Day 0 to Year 5.
Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)
Time frame: Day 0 to month 24
Improvement of overall facial appearance
Time frame: Day 0 to Year 5.
Age of face
Time frame: Day 0 to year 5.
Safety of SPRING THREAD® Elastic Tensor Thread
Time frame: Day 0 to month 12.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ptosis and Ptosis, Mild, run by 1st SurgiConcept at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigator Global Aesthetic Improvement Scale (IGAIS) (time frame: At 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2026.