Safety Evaluation of the Vibrating Capsule

NCT ID: NCT01306448

Last Updated: 2014-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2014-04-30

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.

Conditions

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Constipation

Keywords

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constipation gastro vibrating capsule safety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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vibrating capsule

Group Type EXPERIMENTAL

Vibrant capsule

Intervention Type DEVICE

vibrating capsule

Interventions

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Vibrant capsule

vibrating capsule

Intervention Type DEVICE

Other Intervention Names

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Vibrant

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Vibrant Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tel Aviv Souraski medical Center

Tel Aviv, Israel, Israel

Site Status

Barzilai MC

Ashkelon, , Israel

Site Status

Italian Hospital

Nazeret, , Israel

Site Status

Countries

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Israel

Other Identifiers

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Vibrant-09-MS-CTIL

Identifier Type: -

Identifier Source: org_study_id