ConvaTec has announced the results of a phase 2 study which verified the safety and efficacy of its Vitala continence control device. The Vitala device seals against a patient’s stoma to provide continence, and does not require the patient to wear an ostomy pouch, by storing stool (fæces) inside the body and permitting gasses to vent through an integrated, deodorizing filter. The study followed colostomy patients for 5 months, and found that use of the device resulted in no adverse effects to the stoma, and resulted in higher patient satisfaction than traditional pouch systems.
The multi-center Phase 2 clinical study evaluated the safety and efficacy of the device when worn up to 8 hours a day by individuals with an end colostomy. Participants in the study (n=25) were monitored across treatment stages: usual pouching (21 days), skin barrier transition (14 days), and device wear (107 days). Because Vitala™ CCD seals against the stoma, the study also evaluated stoma vascularity and microbiology.
After the study period of 142 days, results showed that there were no serious adverse events associated with wearing the device. Three participants reported adverse events that were considered related to device wear, none of which led to discontinuation from the study. Throughout the device wear stage, no changes to either stoma vascularity or gut microbiology were observed.
Press release: Phase 2 Clinical Study Demonstrates Safety and Efficacy of Vitala™ Continence Control Device…
Study Abstract at Diseases of the Colon & Rectum: Safety and Efficacy of a Novel Continence Device in Colostomy Patients
Flashback: ConvaTec’s Vitala Continence Control Device Receives FDA OK