Actively Recruiting

Age: 35Years - 75Years
All Genders
NCT05746078

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

Led by 1st SurgiConcept · Updated on 2024-12-12

99

Participants Needed

3

Research Sites

315 weeks

Total Duration

On this page

Sponsors

1

1st SurgiConcept

Lead Sponsor

E

EVAMED

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 35Years - 75Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Men or women aged 35 to 75 years with facial ptosis (cheekbones, jowls), with or without prior aesthetic treatments such as botox, filler, or surgical lift
  • Able to understand the study explanations
  • Informed and willing to participate in the study
  • Able to comply with protocol requirements including follow-up visits
  • Affiliated with social security
Not Eligible

You will not qualify if you...

  • Unable to understand study information or attend study visits
  • Did not give consent to participate
  • Received facial rejuvenation treatment within 3 months before the study
  • Treated with long-term systemic corticosteroids
  • Have visceral failure or chronic immunological disease
  • Pregnant or breastfeeding
  • Participated in another clinical trial involving drugs or medical devices within 30 days prior to inclusion
  • Refuse to participate in the clinical investigation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 3 locations

1

Hôpital Henri Mondor

Créteil, France

Actively Recruiting

2

Hôpital Henri Mondor

Créteil, France

Actively Recruiting

3

Hôpital Pierre Paul Riquet

Toulouse, France, 31000

Not Yet Recruiting

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Research Team

D

Dominique MALARD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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