Clinically Proven. Real-World Evidence. Meaningful Cost Savings.
Peer-reviewed evidence supporting predictable outcomes, long-term safety, and improved patient experience in real-world use.
Coverage that delivers predictable relief—without the side-effect tradeoff.
Vibrant® is an FDA-cleared vibrating capsule system for adults with chronic idiopathic constipation (CIC) who have not achieved relief with laxatives. Real-world community use shows sustained improvements in bowel frequency, stool form, straining, and toileting time with low rates of diarrhea.
Why cover Vibrant®
CIC is common, persistent, and costly when patients cycle therapies due to limited efficacy or tolerability. A non-pharmacologic option with objective, trackable outcomes can reduce friction across the care pathway.
Relief without the “diarrhea tax”
Real-world safety signals show diarrhea reported in 0.64% of patients in the AE summary set, supporting more predictable symptom control.
Sustained improvement over 3–6 months
CSBM frequency increased and maintained over the 3- and 6-month observation windows (see charts below).
Built-in adherence + symptom capture
System activation + optional e-diary enables longitudinal tracking—useful for coverage criteria, step therapy design, and outcomes reporting.
Real-world evidence: outcomes that plans care about
Select an endpoint to view the corresponding chart. Values shown match the study summary provided in your prompt.
Endpoints (click to switch)
- Primary clinical signal Average CSBM/week increased from 1.44 at baseline to 2.37 (3 mo) and 2.51 (6 mo).
- Function + effort + time BSFS moved toward normal, straining decreased, and time on toilet fell to ~15 minutes on average.
- Interpretation note For the “Straining distribution” chart, only Normal and Severe percentages were provided; the middle bucket is computed as remainder (100% − normal − severe).
Safety snapshot
Most reported adverse events were infrequent in the analyzed population; diarrhea was notably uncommon.
| Adverse event | Incidence (%) |
|---|---|
| Any AE | 12.35 |
| Sensation of vibration (bothersome) | 4.60 |
| Delayed capsule expulsion | 2.97 |
| Abdominal pain | 1.81 |
| Bloating / abdominal distension | 1.34 |
| Nausea | 1.28 |
| Diarrhea | 0.64 |
| Gas / flatulence | 0.58 |
| Abdominal discomfort / cramps | 0.47 |
| Vomiting | 0.35 |
| Heartburn | 0.29 |
Operational fit for coverage policy
Suggested levers for a plan-friendly coverage design (edit to your preferred UM posture).
Simple eligibility
Adults with CIC not relieved after ≥1 month of recommended-dose laxative therapy (align language to IFU + your benefit design).
Outcome-based continuation
Continue if patient demonstrates improvement in CSBM/week and/or straining/BSFS within an initial assessment window. The system’s tracking supports straightforward documentation.
Population insights
Aggregate adherence + symptom metrics can support value-based discussions and P&T updates without extra clinic burden.
Request the coverage package
Drop in your actual market access endpoints here (Typeform, HubSpot, email, etc.).
What you can provide (suggested)
AMCP-style dossier • Budget impact model • Coding/billing guidance • Coverage policy language suggestions • RWE slide deck
Long-Term, Real-World Evidence of Vibrating Capsule Treatment
Real-world outcomes demonstrate sustained clinical benefits, improved quality of life, and strong tolerability for patients using Vibrant® for chronic idiopathic constipation (CIC).
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), 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.
Exceptional Patient Outcomes
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Vibrant is a first-in-class, 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.
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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 Placebo
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:
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.
-Satish Rao, MD
| 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 % | — |
Adverse Events:
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.
Request a 1-on-1 Walkthrough
In this 15-minute overview, we’ll review clinical outcomes, long-term safety data, real-world utilization, and answer any questions you have.
Outcomes Backed By Leading Experts
“The data show that this treatment is both effective and well-tolerated by our patients.”
- Darren M. Brenner, MDNorthwestern Medical Group Gastroenterology