PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)

N/ANot Yet RecruitingNCT07068061

21 Century Medical Co., Ltd.50 enrolled

Overview

This clinical investigation aims to confirm the safety and efficacy of the ID in facial soft tissue reconstruction, specifically for non-incision surgery to tighten and lift the facial skin for a rejuvenated facial appearance.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Wrinkles Anti Aging Face-lift

Interventions

PDO sutureDEVICE

A biodegradable polymer used in dissolvable sutures and lifting threads, stimulating collagen production as it degrades.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients over 18 years old with full legal capacity, male and female; * Patients with ability to understand the proposed aesthetic correction and to understand and sign informed consent; * Patients who are willing and able to comply with scheduled visits, aesthetic correction procedure and other trial procedures. Exclusion Criteria: * Pregnant or breast--feeding women; * Patients currently participating in any other clinical investigation; * Patients who have received a vaccine within 14 days prior to the baseline or plan to have vaccine within 14 days after the injection; * Patients with a medical history of systemic diseases, including severe kidney, liver, heart and neurological disorders.

Outcomes

Primary Outcomes

The assessment of improvement in mid-face appearance.

Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).

Time frame: up to 24 weeks

Secondary Outcomes

Further evaluation of improvement of the mid-face appearance.

Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).

Time frame: up to 35 weeks

Self-evaluation of improvement of the mid-face appearance by the Subject.

Proportion of subjects with any improvement compared to baseline, as assessed by the Subject.

Time frame: up to 35 weeks

Number of (S)AEs.

Number of (S)AEs evaluated by the subject using patient diary

Time frame: up to 35 weeks

Central Contacts

Pure Clinical Sp. z o.o

CONTACT

+48739262242 MDsafety@pureclinical.eu

Data from ClinicalTrials.gov

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