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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PDO suture | Device | A biodegradable polymer used in dissolvable sutures and lifting threads, stimulating collagen production as it degrades. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 35 weeks |
| Self-evaluation of improvement of the mid-face appearance by the Subject. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pure Clinical Sp. z o.o | Contact | +48739262242 | MDsafety@pureclinical.eu |
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Proportion of subjects with any improvement compared to baseline, as assessed by the Subject. |
| up to 35 weeks |
| Number of (S)AEs. | Number of (S)AEs evaluated by the subject using patient diary | up to 35 weeks |