A Study of the Performance, Effectiveness and Safety of a Vibrating Capsule Device in Aiding Constipated Individuals

Overview

About this study

This is a study intended to evaluate the effectiveness and safety of the vibrating capsule device versus a sham non-vibrating capsule on spontaneous bowel movement, to aid the relief of constipated individuals.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

Inclusion Criteria

  • Aged 18 years and older
  • Have chronic idiopathic constipation according to Rome III criteria and have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which were used for at least one month at recommended doses)
  • Have more than 1 bowel movement/2 weeks and < 3 bowel movement/week
  • Colonoscopy performed in the past 10 years prior to study participation, unless <50 years old and without alarming signs and symptoms
  • Signed ICF
  • For women with childbearing potential, adequate contraception

Exclusion Criteria

  • History of complicated/obstructive diverticular disease
  • History of intestinal or colonic obstruction
  • History of significant GI disorder
  • Use of following medication: Medication that may affect the bowel mobility, Prokinetics, Anti-Depressants, medications for treatment of Parkinson disease, Opiates, Calcium-channel Blockers, Aluminium/Magnesium Hydroxids
  • Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers
  • Presence of pacemaker
  • History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating
  • Diagnosis of mega-rectum or colon
  • History of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality, including GI resection that affects bowel transit
  • Any evidence of intestinal carcinoma or inflammatory bowel disease or alarm symptoms such as weight loss, rectal bleeding, or anemia
  • History of Zenker's diverticulum, dysphagia or a known esophageal stricture 
  • Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
  • Participation in another clinical study in the last 4 months prior to screening
  • Any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study
  • Women who are pregnant or lactating

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Michael Camilleri, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20192057

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