NCT07195877

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for all trials

Timeline
48mo left

Started Mar 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress22%
Mar 2025Mar 2030

Study Start

First participant enrolled

March 31, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 20, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

September 29, 2025

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2030

Last Updated

September 29, 2025

Status Verified

September 1, 2025

Enrollment Period

5 years

First QC Date

August 20, 2025

Last Update Submit

September 24, 2025

Conditions

Face Tissue Elevation

Keywords

Tissue elevationInfinite-ThreadFaceAestheticInfinite-Thread®permanent tensor threadThread&Lift

Outcome Measures

Primary Outcomes (1)

  • 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

    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)

    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)

    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.

    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).

    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).

    At 3 months, 1, 2, 3, 4, and 5 years follow-up

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Subject aged 18 years old or more who need of facial tissue enhancement.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evamed/1Med

Hérouville-Saint-Clair, 14200, France

RECRUITING

MeSH Terms

Conditions

Facies

Interventions

Mutagenesis, Insertional

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Protein EngineeringGenetic EngineeringGenetic TechniquesInvestigative TechniquesMutationGenetic VariationGenetic PhenomenaMutagenesis

Central Study Contacts

Vincent FOUMENTEZE

CONTACT

+32 (0) 468 38 72 97foumentezevincent@threadandlift.com

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2025

First Posted

September 29, 2025

Study Start

March 31, 2025

Primary Completion (Estimated)

March 31, 2030

Study Completion (Estimated)

March 31, 2030

Last Updated

September 29, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)