Summary:
This study aims to evaluate the performance and safety of a new experimental medical device – the Vibrant Capsule. The purpose of studying this new experimental medical device is to evaluate the Vibrant capsule performance for patients like you, who did not have satisfactory improvement of their chronic constipation symptoms with other available treatment(s). The Vibrant Capsule is designed to mechanically induce a normal peristaltic wave in the large intestine, thus aiding in relieving constipated patients.
This study involves research and there are certain outcomes that are unknown. This is a 3 arm, randomized (the likelihood of getting an active capsule or placebo capsule will be by chance), single- blind (you won’t know which capsule you get), placebo-controlled study. The expected time you will be in the study is 10-11 weeks. Up to 25 study participants will be enrolled at Medical Research South, LLC, and about 168 throughout the study.
Qualified Participants Must:
• Males and females aged 22 and above
• Must have less than 3 bowel movements per week
• Must have tried over the counter, prescription or homeopathic therapies to relieve constipation without success
• If over 50, must have had normal colonoscopy within last 5 years
• Cannot have any disease that may cause constipation: IBS, Diverticular Disease, GI Malignancy, Gastroparesis, etc.
• Certain medications are excluded, including but not limited to: prokinetics, anti-Parkinsonian medications, opiates, opioids, calcium-channel blockers, aluminum/magnesium hydroxide
Qualified Participants May Receive:
$50 per visit. $200 for entire study (4 visits).