PER-SAF_PDOS (Performance and Safety of Polydioxanone Suture)

NCT07068061 | Not Yet Recruiting

• 1 other identifier: PC-MD-CIP-004
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• The assessment of improvement in mid-face appearance.

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

  up to 24 weeks

Secondary Outcomes (3)

• Further evaluation of improvement of the mid-face appearance.

  up to 35 weeks

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

  up to 35 weeks

• Number of (S)AEs.

  up to 35 weeks

Study Arms (1)

Interventional arm

EXPERIMENTAL

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.

Device: PDO suture

Interventions

PDO suture DEVICE

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

Interventional arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• 21 Century Medical Co., Ltd.: lead

Central Study Contacts

Pure Clinical Sp. z o.o

CONTACT

+48739262242; MDsafety@pureclinical.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 16, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 16, 2025

Record last verified: 2025-07