Q: Have there been any medical studies published about this treatment?
A: Up to date, Vibrant has conducted 6 multicenter clinical studies, exploring the safety and efficacy of the device, in over 135 gastro medical centers in the US.
In the recent randomized, multi-center, double-blind, placebo-controlled phase 3 clinical trial with 312 adults patients diagnosed with chronic idiopathic constipation, Vibrant demonstrated significant improvement in incremental complete spontaneous bowel movements.
Patients treated with Vibrant had less straining, more normal stools,
and a better quality of life, compared to placebo group.
Vibrant is proven safe, with no severe adverse events were observed during the clinical trials.
Potential adverse events associated with this device may include abdominal pain, blood in stool, and diarrhea. In rare cases, obstruction may occur.