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

NCT05746078 | Recruiting

• 1 other identifier: ESTES
• Study Type: observational
• Target: 99
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Ptosis; Ptosis, Mild

Keywords

Ptosis, Moderate

Outcome Measures

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.

  At 12 months

Secondary Outcomes (5)

• Patient satisfaction with SGAIS score (Subject Global Aesthetic Improvement Scale)

  Day 0 to Year 5.

• Surgeon satisfaction with IGAIS score (Investigator Global Aesthetic Improvement Scale)

  Day 0 to month 24

• Improvement of overall facial appearance

  Day 0 to Year 5.

• Age of face

  Day 0 to year 5.

• Safety of SPRING THREAD® Elastic Tensor Thread

  Day 0 to month 12.

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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 refusing to participate in the clinical investigation.

Sponsors & Collaborators

• 1st SurgiConcept: lead
• EVAMED: collaborator

Study Sites (3)

Hôpital Henri Mondor

Créteil, France

RECRUITING

Hôpital Henri Mondor

Créteil, France

RECRUITING

Hôpital Pierre Paul Riquet

Toulouse, 31000, France

NOT YET RECRUITING

MeSH Terms

Conditions

Blepharoptosis; Lymphoma, Follicular

Condition Hierarchy (Ancestors)

Eyelid Diseases; Eye Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Dominique MALARD

CONTACT

+33 (0)320 23 41 96; dom@springthread.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2023
• First Posted: February 27, 2023
• Study Start: February 16, 2023
• Primary Completion: March 1, 2025
• Study Completion (Estimated): March 1, 2029
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

FR (3)