Disorder of Soft Tissue Clinical Trial
Official title:
A Multi-center, Open-label, Prospective Study of Implanted Cross-linked HA Device, Aline HA, for Soft Tissue Augmentation, to Treat Only One Anatomic Feature in up to 100 Subjects for 6 Months
The protocol hypothesis is that treatment with Aline HA™ will be safe through 6 months as determined by clinical assessment of treatment sites and routine tracking of adverse events.
A multi-center, open-label, prospective study of implanted cross-linked HA device, Aline HA, for soft tissue augmentation, to treat only one anatomic feature in up to 100 subjects for 6 months. ;
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment