Safety Evaluation of the Vibrating Capsule

Study Overview
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Brief Summary
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The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.

Detailed Description
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Healthy volunteers will be followed for safety for 7 days after taking the capsule. Constipated individuals will be first followed for 2 weeks and than they will use the capsule for 7.5 weeks period. Safety and efficacy will be evaluated.

Official Title
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Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals

Conditions
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Constipation

Intervention / Treatment
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* Device: Vibrant capsule


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients age 18-60 years Ability of subject to understand character and individual consequences of clinical trial Written informed consent must be available before enrollment in the trial For women with childbearing potential, adequate contraception Exclusion Criteria: Patient with Diverticulosis Patient must not use protocol-defined prohibited medicine History of or current diagnosis of cardiovascular ischemic disease (e.g., angina pectoris, myocardial infarction, transient ischemic attack or stroke and including findings suggestive of ischemia on an ECG such as changes in ST segment and T waves, and / or Q wave) Clinical evidence of significant (as judged by the Investigator) respiratory, cardiovascular, renal, hepatic-biliary, endocrine, psychiatric or neurologic diseases or presence of abdominal adhesions Presents of pacemakers History of or current eating disorder such as anorexia or bulimia or compulsory overeating. Diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality including gastrointestinal resection that affected bowel transit or any evidence of intestinal carcinoma, of inflammatory bowel disease or of alarm symptoms such as weight loss, rectal bleeding, or anemia. Actively participating in another clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vibrating capsule<br> | Device: Vibrant capsule<br>* vibrating capsule<br>* Other names: Vibrant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events | Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements | 7.5 weeks of treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spontaneous bowel movement per week compared to baseline | Efficacy will be assessed by increase of more than one complete spontaneous bowel movement per week during the 7.5 weeks of treatment compared to 2 weeks baseline | 9.5 weeks | 
| Patient assessment of capsule tolerability | Comfort and tolerability will be assessed by the patient. Tolerability evaluation will include: assessment of bowel habits, constipation, distention/bloating, abdominal discomfort/pain, patients assessment of impact of constipation on quality of life. | 7.5 weeks of treatment period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, gastro, vibrating capsule, safety