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

Ptosis Clinical Trial

— ESTES  

Official title:

Long-term Assessment of the Performance and Safety of SPRING THREAD® Elastic Tensor Thread.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05746078
• Other study ID #: ESTES
• Status: Recruiting
• Start date: February 16, 2023
• Est. completion date: July 1, 2028

Study information

• Verified date: June 2023
• Source: 1st SurgiConcept
• Contact: Dominique MALARD
• Phone: +33 (0)320 23 41 96
• Email: dom[@]springthread.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 99
• Est. completion date: July 1, 2028
• Est. primary completion date: February 16, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Prolapse
• Ptosis

Locations

Country	Name	City	State
France	Hôpital Henri Mondor	Créteil
France	Hôpital Henri Mondor	Créteil
France	Centre Massilien de la Face	Marseille
France	Hôpital Pierre Paul Riquet	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
1st SurgiConcept	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Day 0 to Year 5.
Secondary	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.	Day 0 to month 24
Secondary	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.	Day 0 to Year 5.
Secondary	Age of face	The age of patient face will be assessed a specific question at each visit.	Day 0 to year 5.
Secondary	Safety of SPRING THREAD® Elastic Tensor Thread	All adverse event will be assessed for the study duration.	Day 0 to month 12.