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The scope of this clinical trial is to evaluate and confirm thereshaping effect of the face with Definisse Threads double needle and Definisse threads free floating insertion, at day 30. 6 clinical follow up visit will be performed
The scope of this clinical trial is to evaluate and confirm thereshaping effect of the face with Definisse Threads double needle and Definisse threads free floating insertion, at day 30. 6 clinical follow up visit will be performed to evaluate the modification of skin surface characteristics, the reshaping effect of the face, the subject's satisfaction at each visit, the presence/absence of the threads after the implantation and the global pain perception during the implant procedure..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Definisse threads free floating and Definisse threads double needle | Experimental | Definisse™ free floating threads will be used with the Soft Tissue Reshaping-2 (STR-2) Technique, to reposition the tissue of the malar area. It is to be used for the face and neck. The thread presents a central area, free of barbs, and two distal areas with barbs. The 12 cm thread will be used in this study. Definisse™ double needle thread (12 cm) that is equipped with barbs in the intermediate section, while the side and the central sections are smooth. The thread ends with two straight cut edge needles 10 cm long Definisse™ double needle threads will be used with the Jawline Reshaping (JR) Technique, to reshape the frame of the jawline, lifting the lower face. This is to be used for the face and the neck. The thread ends with two straight cut edge needles The 12 cm thread will be used in this study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Definisse threads free floating and definisse threads double needle | Device | Definisse threads are two class III medical devices, for evaluate the performance of the reshaping effect of the face at day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of midface and lower face with Definisse threads double needle and Definisse threads free floating insertion at day 30 | The primary objective of this clinical investigation is to evaluate the reshaping effect of the face with Definisse™ thread double needle and Definisse™ thread free floating insertion, at Day 30, through 3D photos and 2D photos, through VECTRA®H2 | up to 30 days of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| reshaping effect between baseline and T15d, T4m, T8m, T12m. | To evaluate the reshaping effect of the face with Definisse™ threads between baseline and day 15, 4 months, 8 months, 12 months with GAIS (Global Aesthetic Improvement Scale; 5-item scale, where 1 = exceptional improvement, 2 = very improved, 3 = improved, 4 = unaltered, 5 = worsened.)) | up to 15 days, 4 months, 8 months and 12 monts of tratment |
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Inclusion Criteria:
Exclusion Criteria:
Absolute exclusion criteria
Subjects presenting one or more of the following absolute exclusion criteria will not be eligible to enter the study.
Relative exclusion criteria
Subjects presenting with one or more of the following relative exclusion criteria will be eligible to enter the study on the basis of the Investigator's evaluation.
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| Name | Affiliation | Role |
|---|---|---|
| Salvatore Fundarò | MULTIMED poliambulatorio and day surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MULTIMED poliambulatorio and day surgery | Bologna | Italia | 40129 | Italy |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 26, 2025 | |
| Reset | Apr 14, 2025 | |
| Release | Jul 10, 2025 | |
| Reset | Jul 29, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 26, 2025 | Apr 14, 2025 | |||
| Jul 10, 2025 |
| ID | Term |
|---|---|
| D019066 | Facies |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Monocentric, prospective, open label, uncontrolled, post-market clinical investigation
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| To evaluate the modification of skin surface characteristics at 30 days, 4 months, 8 months and 12 monts from baseline | Modification of skin surface characteristics in terms of wrinkles, pores and texture, that will be evaluated and quantified at day 30d, 4 months, 8 months, 12 months from baseline through ANTERA 3D. | up to 30 days, 4 months, 8 months and 12 monts of tratment |
| to evaluate the subject's satisfaction at each visit (1 day, 15 days, 30 days, 4 months, 8 months and 12 monts) | Subject's satisfaction self-assessment on the reshaping effect according to the Global Aesthetic Improvement Scale (GAIS: 5-item scale, where 1 = exceptional improvement, 2 = very improved, 3 = improved, 4 = unaltered, 5 = worsened.) at each visit (1 day, 15 days, 30 days, 4 months, 8 months and 12 monts). | up to 1 day, 15 days, 30 days, 4 months, 8 monts and 12 months of treatment |
| To assess the clinical evaluation of reshaping effect of the total, middle and lower face comparing baseline to T15d, T30d, T4m, T8m, T12m by the non-treating investigators | Aesthetic changes of the total, middle and lower face according to the Global Aesthetic Improvement Scale (GAIS: 5-item scale, where 1 = exceptional improvement, 2 = very improved, 3 = improved, 4 = unaltered, 5 = worsened) by the non-treating investigators (one plastic surgeon and one dermatologist) as clinical evaluation of reshaping effect, comparing baseline to T15d, T30d, T4m, T8m, T12m, by evaluating the 2D photos collected by VECTRA®H2 | up to 15 days, 30 days, 4 months,8 months, 12 months of treatment |
| To evaluate the presence/absence of the threads after the implantation at T30d, T4m, T8m, T12m | Presence/absence of the thread in the implant area after 30 days, 4 months, 8 months and 12 monts from the treatment with an ultrasound evaluation. | up to 30 days, 4 months, 8 months, 12 months of treatment |
| To evaluate the global pain perception during the implant procedure at T1d and T15d. | Global pain perception during the implant procedure at 1 day and at the first follow-up visit (15 days) by a numeric pain scale (NRS: from "0" (No pain) to "10" (worst possible pain)). | up to 1 and 15 days of treatment |
| To evaluate the subject's self-esteem at each visit (1 day, 15 days, 30 days, 4 months, 8 months and 12 monts) T30d, T4m, T8m, T12m). | Subject's self-esteem by the Rosenberg Self-Esteem Scale at each visit ( This scale is a widely used self-report instrument for evaluating individual self-esteem. The scale ranges from 0 to 30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.)(1 day, 15 days, 30 days, 4 months, 8 months and 12 monts) | up to 1 day, 15 ddays, 30 days, 4 months, 8 month, 12 months of treatment |
| Jul 29, 2025 |