Safety Evaluation of the Vibrating Capsule (Vibrant)

Vibrant

Status

Completed

Conditions

Constipation

Treatments

Device: Vibrant capsule

Study type

Interventional

Funder types

Industry

Identifiers

NCT01306448

Vibrant-09-MS-CTIL

Details and patient eligibility

About

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

Full 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.

Enrollment

26 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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