Factory
has experience in the preparation and execution of different medical device trial
designs including 'phase I-IV' clinical trials, Safety & Performance studies,
efficacy studies, effectiveness studies, clinical economic studies, Quality of
Life studies, and Post Marketing Studies.
We have performed multi-centre
clinical trials with 20 to 300 patients per study, recruited by 2 to 20 participating
investigators in up to 8 different European countries. Follow up periods for clinical
device trials vary from 1 month to 2 years depending on the calculated safety
risks of the device.
We are experienced in evaluating devices in a number
of different surgery disciplines,
which you can find listed below.
| -
Morbid obesity | | | -
Hand assisted laparoscopic surgery | | | -
Endoscopic surgery | | | -
Continence preservation | | | -
Electro surgery | | | -
Intra-abdominal adhesion prevention
| | | - Pancreatic
stenting | | | - Inguinal
hernia repair | | | - Tissue
glue |
| -
Endovascular stenting | | | -
Endovascular embolisation | | | -
Tissue glue, hemostatic and surgical sealants
| | | - Endocardiovascular
CPB | | | - Cardiac
adhesion prevention |
| -
Bone defect studies | | | -
Cartilage replacement | | | -
Osteosynthesis, biodegradable and non absorbable
| | | - Endoscopic
spine surgery | | | - Maxillofacial
surgery |
| -
Trans myocardial revascularisation | | | -
Adhesion prevention | | | -
Endoscopic lung resection | | | -
Lung air-leak sealant |
| -
Nefrectomy techniques | | | -
Bladder replacement procedures | | | -
Incontinence therapies |
| -
Endovascular stenting | | | -
Endovascular embolisation | | | -
Surgical hemostatics and sealants |
|