Safety Evaluation of the Vibrating Capsule

NCT01306448 | Completed

• 1 other identifier: Vibrant-09-MS-CTIL
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Constipation

Keywords

constipation; gastro; vibrating capsule; safety

Outcome Measures

Primary Outcomes (1)

• Number of patients with adverse events

  Safety will be assessed descriptively by summarizing AEs, clinical laboratory test results, vital sign measurements, and ECG measurements

  7.5 weeks of treatment period

Secondary Outcomes (2)

• Change in spontaneous bowel movement per week compared to baseline

  9.5 weeks

• Patient assessment of capsule tolerability

  7.5 weeks of treatment period

Study Arms (1)

vibrating capsule

EXPERIMENTAL

Device: Vibrant capsule

Interventions

Vibrant capsule DEVICE

vibrating capsule

Also known as: Vibrant

vibrating capsule

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Vibrant Ltd.: lead

Study Sites (3)

Tel Aviv Souraski medical Center

Tel Aviv, Israel, Israel

Location

Barzilai MC

Ashkelon, Israel

Location

Italian Hospital

Nazeret, Israel

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: March 1, 2011
• Study Start: March 1, 2011
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12

Locations

IL (3)