All products developed by Wellspect undergo a clinical study program where product safety and performance are carefully evaluated and determined.
Wellspect’s clinical study program is developed and conducted together with leading clinicians in the field. All our studies are conducted according to Good Clinical Practice (GCP), the Declaration of Helsinki, Wellspect HealthCare Standard Operating Procedures (SOP) and applicable rules and regulations. Compliance with the international standard ISO 14155 on clinical investigations of medical devices for human subjects.
Post-market product surveillance is performed to gain further knowledge about safety and performance of our products in clinical use after release on the market. Monitoring products in this phase may include clinical research, literature reviews or surveys.
Examples of our latest studies;
- An open prospective study on the efficacy of Navina Smart, an electronic system for transanal irrigation, in neurogenic bowel dysfunction
Emmanuel et al 2021
- Intermittent catheterization with single or multiple reuse catheters:
clinical study on safety and impact on quality of life
- Short Term Evaluation of a Novel Eletronic Transanal Irrigation System in Patients with Neurogenic Bowel Dysfunction Previously Exposed to Transanal Irrigation Systems
Passananti et al. 2018
- Review on reuse versus single-use catheters for intermittent catheterization
- New, more environmentally friendly, catheter material
Johansson et al. 2013