PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)

Evaluation of the Performance and Safety of Polydioxanone Suture (PDO) Bio Meyisun for the Temporary Correction of the Mid-face Area.

Status

Not yet recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07068061

Acronym

PER-SAF_PDOS

Enrollment

Registered

2025-07-16

Start date

2025-09-01

Completion date

2026-07-01

Last updated

2025-07-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti Aging, Face-lift, Wrinkles

Brief summary

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.

Interventions

DEVICEPDO suture

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
The assessment of improvement in mid-face appearance.	up to 24 weeks	Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).

Secondary

Measure	Time frame	Description
Further evaluation of improvement of the mid-face appearance.	up to 35 weeks	Proportion of subjects with any improvement compared to baseline, as assessed by the Independend Evaluator (IE).
Self-evaluation of improvement of the mid-face appearance by the Subject.	up to 35 weeks	Proportion of subjects with any improvement compared to baseline, as assessed by the Subject.
Number of (S)AEs.	up to 35 weeks	Number of (S)AEs evaluated by the subject using patient diary

Contacts

Primary ContactPure Clinical Sp. z o.o

MDsafety@pureclinical.eu+48739262242

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026