Face Tissue ElevationNCT07195877
Real-life Assessement of Safety and Perofmance of the of the "Infinite-Thread®" Permanent Tensor Thread
An observational study of Face Tissue Elevation, run by Thread and Lift at 1 site in France.
Trial summary
The purpose of this post-market clinical follow-up is to assess the safety and performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face. The study will assess the safety result up to 5 years after the intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Face Tissue Elevation
- What is being tested?
- Insertion/placement of tension threads
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 127 participants
- Where
- 1 siteFrance
- Study dates
- 31 Mar 2025to 31 Mar 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subject aged 18 years old or more who need of facial tissue enhancement.
Who may be able to join
- Subject aged 18 years or older
- Subject informed and not opposed to participating in the study
- Subject to be implanted with at least one Infinite-Thread® tension thread
- Person affiliated with a heallth care system/inssurance
Who cannot join
- Pregnant or breastfeeding women
- Contraindications (allergy to components, infection, systemic diseases)
- Subject prones to chronic pain
- Person deprived of liberty, under guardianship/curatorship, or under judicial protection
- Subject refusing to commit to not resorting to the following procedures during the 5 years following their intervention: Surgical facelift, Deep phenol peel, CO2 laser resurfacing \& Lipofilling
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Evamed/1Med
Hérouville-Saint-Clair, 14200
Justine COLOMBEL, +33 (0)2.31.93.21.18, justine.colombel@1med.net
Jean-Paul FOUMENTEZE
About this study
Official title: Real-life Assessment of the Safety and Performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face, From the Thread & Lift Laboratory
The purpose of this post-market clinical follow-up is to assess the safety and performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face. The study will assess the safety result up to 5 years after the intervention.
- Conditions
- Face Tissue Elevation
- Being tested
- Insertion/placement of tension threads
- Keywords
- Tissue elevation, Infinite-Thread, Face, Aesthetic, Infinite-Thread®, permanent tensor thread, Thread&Lift
- Medical subject headings
- Facies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Insertion/placement of tension threadsDevice
- Standard preoperative anti-staphylococcal antibiotic prophylaxis by intramuscular injection.
- Disinfection of the surgical area.
- Marking of the paths of the threads to be implanted according to the physician's choice.
- Placement of sterile surgical drapes.
- Local anesthesia of the paths.
- Implantation of a needle (manufactured by Thread \& Lift) and pulling of the threads into the subcutaneous tissue. Adjustment of the tension of all the implanted threads. Cutting of the ends of the threads.
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess medical device safety at 5 years after intervention.
The rate of sequelae and complications related to the device or procedure within 5 years after the intervention
Measured: at 5 years follow-up
Secondary outcomes (5)
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the subject (overall and by area)
Completion of effectiveness score by patient (GAIS) (overall and by area). It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
Measured: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the physician (overall and by area)
Completion of effectiveness score by physician (GAIS) (overall and by area). It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
Measured: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the physician.
Physician effectiveness scale (5-point ordinal scales) by area. Values range from 0 to 4. 0 is the minimum value and the best (Non-sagging or non-marked area). 4 is the maximum and the worse value (Area that is significantly sagging or marked).
Measured: At 3 months, 1, 2, 3, 4, and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the independant assessor (physician) (overall and by area).
Completion of effectiveness score by independant assessor (physician) (GAIS) (overall and by area). Blind analysis of picture.
It's a 5 points scale (1 to 5). The minimum value is 1 associated to a significant improvement and the maximum value is 5 associated to significant deterioration/worse.
Measured: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the independent assessor (physician).
Independent assessor (physican) effectiveness scale (5-point ordinal scales) by area. Blind analysis of picture.
Values range from 0 to 4. 0 is the minimum value and the best (Non-sagging or non-marked area). 4 is the maximum and the worse value (Area that is significantly sagging or marked).
Measured: At 3 months, 1, 2, 3, 4, and 5 years follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2025
- Study start31 Mar 2025
- Primary completion31 Mar 2030 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Face Tissue ElevationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 127 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thread and Lift
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07195877
- Sponsor's protocol ID
- FILS-TENSEURS
- Other IDs
- 2024-A02819-38
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 29 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-life Assessment of the Safety and Performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face, From the Thread & Lift Laboratory
- ClinicalTrials.gov ID
- NCT07195877
- Acronym / sponsor ID
- FILS-TENSEURS
- Conditions
- Face Tissue Elevation
- Keywords
- Tissue elevation, Infinite-Thread, Face, Aesthetic, Infinite-Thread®, permanent tensor thread, Thread&Lift
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 127 participants (estimated)
- Lead sponsor
- Thread and LiftIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 31 Mar 2025 (actual)
- Primary completion
- 31 Mar 2030 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 29 Sep 2025 (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 is to assess the safety and performance of the "Infinite-Thread®" Permanent Tensor Thread on the Face. The study will assess the safety result up to 5 years after the intervention.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subject aged 18 years old or more who need of facial tissue enhancement.
Key inclusion criteria (4 listed)
- Subject aged 18 years or older
- Subject informed and not opposed to participating in the study
- Subject to be implanted with at least one Infinite-Thread® tension thread
- Person affiliated with a heallth care system/inssurance
Key exclusion criteria (5 listed)
- Pregnant or breastfeeding women
- Contraindications (allergy to components, infection, systemic diseases)
- Subject prones to chronic pain
- Person deprived of liberty, under guardianship/curatorship, or under judicial protection
- Subject refusing to commit to not resorting to the following procedures during the 5 years following their intervention: Surgical facelift, Deep phenol peel, CO2 laser resurfacing \& Lipofilling
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Insertion/placement of tension threads* Standard preoperative anti-staphylococcal antibiotic prophylaxis by intramuscular injection. * Disinfection of the surgical area. * Marking of the paths of the threads to be implanted according to the physician's choice. * Placement of sterile surgical drapes. * Local anesthesia of the paths. * Implantation of a needle (manufactured by Thread \& Lift) and pulling of the threads into the subcutaneous tissue. Adjustment of the tension of all the implanted threads. Cutting of the ends of the threads. | Device | – |
Primary outcome
To assess medical device safety at 5 years after intervention.
Time frame: at 5 years follow-up
The rate of sequelae and complications related to the device or procedure within 5 years after the intervention
5 secondary outcomes
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the subject (overall and by area)
Time frame: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the physician (overall and by area)
Time frame: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the physician.
Time frame: At 3 months, 1, 2, 3, 4, and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by the independant assessor (physician) (overall and by area).
Time frame: At 3-months, 1,2,3,4 and 5 years follow-up
To assess the effectiveness of the Infinite-Thread® permanent tension thread by area by the independent assessor (physician).
Time frame: At 3 months, 1, 2, 3, 4, and 5 years follow-up
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 29 Sep 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Face Tissue Elevation, run by Thread and Lift at 1 site 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 4 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Vincent FOUMENTEZE (+32 (0) 468 38 72 97, foumentezevincent@threadandlift.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess medical device safety at 5 years after intervention. (time frame: at 5 years follow-up). 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 29 Sep 2025.