PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)

NCT ID: NCT07068061

Last Updated: 2025-07-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2026-07-01

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.

Conditions

Wrinkles; Anti Aging; Face-lift

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Interventional arm

The procedure will start with skin cleansing using an antiseptic and careful marking of entry and exit points for thread placement. Aesthetic cream and local anaesthesia will be applied to enhance patient comfort before inserting PDO barbed threads into the subdermal layer using a cannula. The threads will be adjusted to create a natural-looking lift, followed by manual lifting to anchor them securely within the tissue. Finally, any excess thread will be trimmed, the area massaged for proper positioning, and the skin cleaned again to maintain sterility.

Group Type: EXPERIMENTAL

PDO suture

Intervention Type: DEVICE

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

Interventions

PDO suture

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

21 Century Medical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Pure Clinical Sp. z o.o

Role: CONTACT

MDsafety@pureclinical.eu

+48739262242

Other Identifiers

PC-MD-CIP-004

Identifier Type: -

Identifier Source: org_study_id