The data demonstrated that the Vibrant’s capsule increased complete bowel movement frequency, constipation symptoms, and quality of life in individuals with CIC while maintaining a safe and well-tolerated safety profile
Vibrant Gastro announces data results from positive Phase 3 study of its proprietary, drug-free treatment for CIC. (Credit: valelopardo from Pixabay)
Medical technology company Vibrant Gastro announced the data results from a positive Phase 3 study of its proprietary, drug-free treatment for chronic idiopathic constipation (CIC).
The data demonstrated that the Vibrant’s capsule increased complete bowel movement frequency, constipation symptoms, and quality of life in individuals with CIC while maintaining a safe and well-tolerated safety profile.
The Vibrant System was tested in 312 CIC patients in a Phase 3 study at over 90 clinical facilities across the US.
The Phase 3 results fulfilled all primary goals for complete spontaneous bowel movements (CSBMs) per week and showed improvement in secondary outcomes as compared to placebo.
According to the study, no adverse events or treatment-related diarrhoea or nausea were reported.
Vibrant Gastro chief executive officer Lior Ben-Tsur said: “This research demonstrates that Vibrant’s unique drug-free mechanism of action significantly improves patients’ overall constipation symptoms and quality of life.
“Vibrant offers healthcare providers a new tool to expand chronic constipation treatment options and may provide a cost-effective solution for chronic constipation for health systems and insurance companies.”
The treatment is based on the scientific insight that the circadian rhythm, or biological clock, plays a crucial part in a human’s biological digestion process.
Vibrant’s technology resynchronizes the biological clock by mechanically stimulating the colon, leveraging the Gut-Brain connection for improved bowel movements and a higher quality of life.
Vibrant CCO Catherine Collis said: “Additionally, as we innovate in the gastroenterology space, we have the opportunity to help millions of CIC patients gain access to novel drug-free treatments that offer predictable, affordable, and effective choices to manage their frequent and bothersome symptoms.”
The medical technology company has submitted its system for clearance to the US Food and Drug Administration based on the Phase 3 findings.
The data was presented at the 2022 Digestive Disease Week Conference.