Clinical Research Directory

Evaluation of Performance and Safety of Injectable KIO017 Device Range for Facial Tissue Filling

The goal of this clinical trial is to primarily evaluate the performance of KIO017 in filling/volumizing after injection in different areas in healthy women or men, older than 18 years and seeking an improvement of her/his face aspect with resorbable filler. The main questions it aims to answer are: If the products are safe \- Acceptable local tolerance, with acceptable clinical signs after injection. If the clinical performance is as intended compared to baseline * Evaluation of performance by assessing the improvement of the appearance of the defect to be corrected by using Global Aesthetic Improvement Scale (GAIS) * Quantification of the improvement using the appropriate scale when available or other appropriates tool (angle for chin, for instance). * Pain felt during injection and after injection * Subject satisfaction

Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.

This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation. While micropigmentation is standard in nipple-areola complex (NAC) reconstruction, HA use remains novel, with limited data on psychosocial, sexual, and aesthetic outcomes. A sequential explanatory mixed-methods design will be used. In Phase 1, a randomized controlled trial will compare two groups: one receiving NAC micropigmentation alone (control) and the other receiving micropigmentation plus HA-based nipple projection (intervention). A total of 138 participants will be recruited at the Areolar Micropigmentation Unit of Germans Trias i Pujol University Hospital (Barcelona) over 36 months. Outcomes will include psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection, measured using the Spanish BREAST-Q, a custom satisfaction tool, and calipers. Phase 2 will involve a qualitative phenomenological study using semi-structured interviews with a purposive sample from the intervention group. Thematic analysis will explore body image, emotional and social well-being, and overall satisfaction, using NVivo software. This is the first study assessing HA nipple reconstruction by advanced practice nurses using validated patient-reported outcomes. While the BREAST-Q is appropriate, it may not fully capture emotional nuances, justifying qualitative exploration. HA durability is estimated at 6-9 months, but residual volume and satisfaction over time remain underexplored. HA's aesthetic footprint may allow reduced dosages in future applications. This minimally invasive technique may reduce the need for surgical nipple reconstruction. Conducting the procedure in a nurse-led setting is novel and may enhance patient-centered care and the role of nursing in post-mastectomy recovery. The study complies with the Declaration of Helsinki and Spanish biomedical regulations. Ethical approval was obtained. Participants will provide informed consent, and data will be anonymized and securely stored.

Purpose of This Study is the Demonstration of Safety and Efficacy of the Dermal Fillers DXP01 Temporary Improvement of Moderate to Severe Nasolabial Folds

Purpose of this study is the demonstration of safety and efficacy of the dermal fillers DXP01 Face for restoration of moderate to severe nasolabial folds