Back to resultsSafety Evaluation of the Vibrating Capsule (Vibrant)
Primary Purpose
Constipation
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Vibrant capsule
Sponsored by
About this trial
This is an interventional treatment trial for Constipation focused on measuring constipation, gastro, vibrating capsule, safety
Eligibility Criteria
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
Sites / Locations
- Barzilai MC
- Italian Hospital
- Tel Aviv Souraski medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
vibrating capsule
Arm Description
Outcomes
Primary Outcome Measures
Number of patients with adverse events
Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements
Secondary Outcome Measures
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01306448
Brief Title
Safety Evaluation of the Vibrating Capsule
Acronym
Vibrant
Official Title
Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vibrant Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will assess the safety of the vibrating capsule in healthy volunteers first and than for constipation relief constipated individuals.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
constipation, gastro, vibrating capsule, safety
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
vibrating capsule
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Vibrant capsule
Other Intervention Name(s)
Vibrant
Intervention Description
vibrating capsule
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Description
Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements
Time Frame
7.5 weeks of treatment period
Secondary Outcome Measure Information:
Title
Change in spontaneous bowel movement per week compared to baseline
Description
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
Time Frame
9.5 weeks
Title
Patient assessment of capsule tolerability
Description
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.
Time Frame
7.5 weeks of treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Barzilai MC
City
AShkelon
Country
Israel
Facility Name
Italian Hospital
City
Nazeret
Country
Israel
Facility Name
Tel Aviv Souraski medical Center
City
Tel Aviv
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Safety Evaluation of the Vibrating Capsule
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