How Vibrant Works
Unique mechanism of action designed to stimulate the colon’s natural rhythm
In patients with chronic idiopathic constipation (CIC), colon activity is often out of sync.
Vibrant is a capsule that, when activated and swallowed, sends out pulsed micro-vibrations to stimulate the colon locally, which induces peristalsis and helps the colon contract mechanically, synchronizing with its biological clock.
Proven effective and safe in clinical trials
Vibrant is a novel, non-pharmacological, intraluminal therapy that is proven to be efficacious and safe in patients with chronic idiopathic constipation (CIC).
It is indicated for the treatment of adults with chronic idiopathic constipation who have not experienced relief of their bowel symptoms by using laxative therapies at the recommended dosage for at least 1 month.
Study design
Randomized, double-blind, multi-center, placebo-controlled phase 3 clinical trial with 312 adult patients diagnosed with chronic idiopathic constipation.
The primary efficacy end points were an increase of 1 or more complete spontaneous bowel movements per week (CSBM responder) or 2 or more CSBMs per week (CSBM ) from baseline during at least 6 of the 8 weeks.
Significant improvements across all efficacy measures
Primary Endpoints
p=0.001
p=0.008
Treatment Arm
Vibrant
Placebo
- Vibrant Capsule led to one additional bowel movement in approximately 40% of patients compared with 23% of people who were in the control arm2
- Approximately 23% of people taking Vibrant had two additional bowel movements per week, compared with approximately 12% of people taking placebo2
Secondary Endpoints
constipation symptoms
Straining Score
Stool Consistency
Treatment Arm
Vibrant
Placebo
Conclusions
Vibrant demonstrated significant improvement in
- stool frequency, which was seen as early as week 1 and continued throughout the study.
- other bowel and abdominal symptoms and quality of life.
The regimen established tolerability with no significant adverse events.
Vibrant provides a novel, non-pharmacological, intraluminal therapy that is effective, safe, and well tolerated in patients with CIC.2
See key thought leaders respond to the clinical data for Vibrant
Safety
Vibrant should not be used if your patient
- has a history of complicated/obstructive diverticular disease.
- has a history of intestinal or colonic obstruction, or suspected intestinal obstruction.
- currently has clinical evidence of significant gastroparesis.
- has a history of significant gastrointestinal disorder, including any form of inflammatory bowel disease or gastrointestinal malignancy (celiac disease is excepted if the subject has been treated and is in remission), and/or anal fissures and fistulas.
- has a history of Zenker’s diverticulum, dysphagia, esophageal stricture, eosinophilic esophagitis, or achalasia.
- is pregnant or lactating.
Adverse events/side effects:
Potential adverse events associated with the use of this device may include abdominal pain, abdominal distension, abdominal discomfort, vomiting, nausea, blood in stool, diarrhea, flatulence, and proctalgia. In rare cases, obstruction may occur.
Note that the safety and effectiveness of the Vibrant System for long-term use in the indicated population, i.e., for more than 8 weeks, has not been evaluated.
Warnings:
- The Vibrant Capsule is MR unsafe. The device has not been evaluated for safety and compatibility in the MR (magnetic resonance) environment. It has not been tested for heating, migration, or image artifact in the MR (magnetic resonance) environment. If patient requires an MRI, verify Capsule expulsion via abdominal X-ray before undergoing an MRI examination.
- The Capsule should be kept away from implants such as pacemakers, defibrillators, nerve stimulators, and other devices that could be affected by proximity to a DC (direct current) magnetic field.
- Vibrant Capsules must be stored in a safe place, out of the reach of children and/or infants.
- If a child has accidentally swallowed an unused Vibrant Capsule, he/she should be brought immediately to a hospital.
- The Vibrant Capsule is magnetic resonance (MR) unsafe. If an MRI is required, verify that no Capsules are currently in your body via abdominal X-ray before undergoing an MRI examination.