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Completed

NCT Number: NCT01306448

Safety Evaluation of the Vibrating Capsule

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tel Aviv Souraski medical Center, Tel Aviv, Israel

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibrant capsule

Device

vibrating capsule

Other names: Vibrant

Primary outcomes

  1. Number of patients with adverse events

    Time frame: 7.5 weeks of treatment period

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

Secondary outcomes

  1. Change in spontaneous bowel movement per week compared to baseline

    Time frame: 9.5 weeks

    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

  2. Patient assessment of capsule tolerability

    Time frame: 7.5 weeks of treatment period

    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.

Sponsors and collaborators

Lead sponsor

Vibrant Ltd.

Industry

Registry information

Official study title

Safety Evaluation of the Vibrating Capsule in Aiding Reliving Constipated Individuals

Acronym: Vibrant

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 1, 2011
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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