Long-Term, Real-World Evidence of Vibrating Capsule Treatment
Improved Bowel Frequency
Patients using Vibrant experienced a >1 additional complete spontaneous bowel movement (CSBM) per week compared to baseline over 3 and 6 months.
Enhanced Stool Consistency
Average Bristol Stool Form Scale (BSFS) scores improved from approximately 2.9 → 4.1, indicating softer, more normal stool form and easier passage.
Reduced Straining and Toileting Time
Patients reported less straining (2.9 → 1.6) and shorter time spent on the toilet (p < 0.0001 for both parameters), reflecting improved bowel efficiency and comfort.
Well-Tolerated and Safe
Adverse events were rare — only 0.64% of patients reported diarrhea, and no serious device-related adverse events occurred.
Phase 3 Randomized, Placebo-Controlled Trial
In a double-blind, placebo-controlled Phase 3 trial in adults with chronic idiopathic constipation, Vibrant demonstrated significantly higher responder rates for complete spontaneous bowel movements and significant improvements in multiple secondary symptom and quality-of-life measures.2
Vibrant Placebo
- Vibrant Capsule led to one or more additional complete spontaneous bowel movements per week in 39.3% of patients, compared with 22.1% in the placebo arm.2
- 22.7% of patients taking Vibrant achieved two or more additional complete spontaneous bowel movements per week, compared with 11.4% taking placebo.2
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.
| 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 % | — |
Approved Use
Vibrant is a 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.
“The other striking thing was the side effects. Virtually none. ‘Hardly anybody felt this.’ ‘There was no diarrhea.’ The combination of highly efficacious data with very minimal or no side effects is a brilliant package.”
“ I feel like a normal human being again! ”
★★★★★
Cherie F, Chicago
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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
See Vibrant in Action
Short videos on how the Vibrant System® works and what to expect — tap any clip to play.
Request a 1-on-1 Clinician Walkthrough
Learn how Vibrant® 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.
Prefer to talk now? Call 866-359-7532 (press 1 for VibrantConnect) or email service@vibrantgastro.com.