Safety Evaluation of the Vibrating Capsule (Vibrant)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Vibrant Ltd.
Sponsor:
Information provided by (Responsible Party):
Vibrant Ltd.
ClinicalTrials.gov Identifier:
NCT01306448
First received: February 21, 2011
Last updated: January 5, 2014
Last verified: January 2014

February 21, 2011
January 5, 2014
March 2011
April 2014   (final data collection date for primary outcome measure)
Number of patients with adverse events [ Time Frame: 7.5 weeks of treatment period ] [ Designated as safety issue: Yes ]
Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements
Same as current
Complete list of historical versions of study NCT01306448 on ClinicalTrials.gov Archive Site
  • Change in spontaneous bowel movement per week compared to baseline [ Time Frame: 9.5 weeks ] [ Designated as safety issue: No ]
    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
  • Patient assessment of capsule tolerability [ Time Frame: 7.5 weeks of treatment period ] [ Designated as safety issue: No ]
    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.
Same as current
Not Provided
Not Provided
 
Safety Evaluation of the Vibrating Capsule
Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals

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

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.

Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Constipation
Device: Vibrant capsule
vibrating capsule
Other Name: Vibrant
Experimental: vibrating capsule
Intervention: Device: Vibrant capsule
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
April 2014
April 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 60 Years
Yes
Contact: Ron Yishai, Dr. 03-6970700 yishair@tasmc.health.gov.il
Israel
 
NCT01306448
Vibrant-09-MS-CTIL
No
Vibrant Ltd.
Vibrant Ltd.
Not Provided
Not Provided
Vibrant Ltd.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP