Chronic Idiopathic Constipation

  • STATUS
    Recruiting
Updated on 5 February 2021
constipation
chronic constipation
constipation, chronic
chronic idiopathic constipation

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, 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.

Description

The Vibrant capsule is medication-free, does not interact with any other body system and does not deliver medication of any kind. The capsule will be secreted from your body in its entirety with normal bowel movement (through the stool).
 
The study involves 4 outpatient visits over 12 weeks. Compensation for time and travel is provided.

Details
Condition Constipation
Clinical Study IdentifierTX264549
Last Modified on5 February 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Be age 22 and older
Have Chronic Idiopathic Constipation (constipation that is of unknown origin)

Exclusion Criteria

Have a history of significant gastrointestinal disorder (gastroparesis, Inflammatory bowel disease, etc)
Have a history of an eating disorder
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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