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
  Purpose

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


Condition Intervention
Constipation
Device: Vibrant capsule

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals

Resource links provided by NLM:


Further study details as provided by Vibrant Ltd.:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: vibrating capsule Device: Vibrant capsule
vibrating capsule
Other Name: Vibrant

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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01306448

Contacts
Contact: Ron Yishai, Dr. 03-6970700 yishair@tasmc.health.gov.il

Locations
Israel
Barzilai MC Not yet recruiting
AShkelon, Israel
Contact: Shmuel Delgado, MD    972-54-6340366    shmueld@barzi.health.gov.il   
Principal Investigator: Shmuel Delgado, MD         
Italian Hospital Not yet recruiting
Nazeret, Israel
Contact: Rifaat Safadi       SAFADI@hadassah.org.il   
Principal Investigator: Rifaat Safadi, MD         
Tel Aviv Souraski medical Center Recruiting
Tel Aviv, Israel
Contact: Ron Yishai, MD    972-52-4266852    yishair@tasmc.health.gov.il   
Principal Investigator: Ron Yishai         
Sponsors and Collaborators
Vibrant Ltd.
  More Information

No publications provided

Responsible Party: Vibrant Ltd.
ClinicalTrials.gov Identifier: NCT01306448     History of Changes
Other Study ID Numbers: Vibrant-09-MS-CTIL
Study First Received: February 21, 2011
Last Updated: January 5, 2014
Health Authority: Israel: Ministry of Health

Keywords provided by Vibrant Ltd.:
constipation
gastro
vibrating capsule
safety

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014