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

NCT ID: NCT05746078

Last Updated: 2024-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

99 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-16

Study Completion Date

2029-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ptosis Ptosis, Mild

Keywords

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Ptosis, Moderate

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EVAMED

OTHER

Sponsor Role collaborator

1st SurgiConcept

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hôpital Henri Mondor

Créteil, , France

Site Status RECRUITING

Hôpital Henri Mondor

Créteil, , France

Site Status RECRUITING

Hôpital Pierre Paul Riquet

Toulouse, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Dominique MALARD

Role: CONTACT

Phone: +33 (0)320 23 41 96

Email: [email protected]

Facility Contacts

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Barbara HERSANT, Pr

Role: primary

Jean-Paul MENINGAUD, Pr

Role: primary

Céline DEKEISTER, Dr

Role: primary

Other Identifiers

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ESTES

Identifier Type: -

Identifier Source: org_study_id