The path to relief from constipation* starts with safe, effective Vibrant®.
“I feel like a normal human being again”
- Cherie F, Chicago, a patient with chronic constipation
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“I love the fact that it’s not another drug. I’ve eaten handfuls of laxatives & drank every nasty liquid solution there is – without success… With Vibrant, I now have bowel movements 3 – sometimes 4 – times each week. My stomach is not as distended; I’ve lost at least 20 pounds, & I feel like a normal human being again.”— Cherie F., a patient from Chicago
Hear from Leading Gastroenterologists
“The phase three data show that this treatment is both effective and well-tolerated by our patients.”
- Darren M. Brenner, MDNorthwestern Medical Group Gastroenterology
Approved Use
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.
Clinical Endpoints
Randomized, double-blind, multi-center, placebo-controlled phase 3 clinical trial with 312 adult patients diagnosed with chronic idiopathic constipation. The primary endpoints were an increase of 1 or more complete spontaneous bowel movements per week (CSBM responder) or 2 or more CSBMs per week from baseline during at least 6 of the 8 weeks.
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
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.
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.
- 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 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.
Efficacy & Safety Data:
Primary Endpoints
- Vibrant Capsule led to one additional bowel movement in approximately 40% of patients compared with 23% of people who were in the control arm.2
- Approximately 23% of people taking Vibrant had two additional bowel movements per week, compared with approximately 12% of people taking placebo.2
Secondary Endpoints:
Adverse Events:
| Vibrant | Placebo | |
|---|---|---|
| Gastrointestinal disorders – total | 6.13 % | 9.40 % |
| Abdominal pain | 0.61 % | 4.03 % |
| Vomiting | 1.23 % | 0.67 % |
| Nausea | 1.84 % | 0.67 % |
| Abdominal distension | 0.61 % | 1.34 % |
| Diarrhea | 1.23 % | — |
Request a 1 on 1 Clinician Walkthrough
Learn how Vibrant Gastro® delivers drug-free, FDA-cleared relief for CIC with a 15-minute walkthrough. We’ll cover how it works, prescribing details, and answer any questions you have.