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Safety Evaluation of the Vibrating Capsule (Vibrant)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01306448
Recruitment Status : Completed
First Posted : March 1, 2011
Last Update Posted : December 10, 2014
Information provided by (Responsible Party):
Vibrant Ltd.

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

Condition or disease Intervention/treatment Phase
Constipation Device: Vibrant capsule Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals
Study Start Date : March 2011
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Experimental: vibrating capsule Device: Vibrant capsule
vibrating capsule
Other Name: Vibrant

Primary Outcome Measures :
  1. Number of patients with adverse events [ Time Frame: 7.5 weeks of treatment period ]
    Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements

Secondary Outcome Measures :
  1. Change in spontaneous bowel movement per week compared to baseline [ Time Frame: 9.5 weeks ]
    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

  2. Patient assessment of capsule tolerability [ Time Frame: 7.5 weeks of treatment period ]
    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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01306448

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Barzilai MC
AShkelon, Israel
Italian Hospital
Nazeret, Israel
Tel Aviv Souraski medical Center
Tel Aviv, Israel
Sponsors and Collaborators
Vibrant Ltd.
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Responsible Party: Vibrant Ltd. Identifier: NCT01306448    
Other Study ID Numbers: Vibrant-09-MS-CTIL
First Posted: March 1, 2011    Key Record Dates
Last Update Posted: December 10, 2014
Last Verified: December 2014
Keywords provided by Vibrant Ltd.:
vibrating capsule
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms