A Study of the Performance, Effectiveness and Safety of a Vibrating Capsule Device in Aiding Constipated Individuals
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 15-000066
NCT ID: NCT02030756
Sponsor Protocol Number: 15-000066
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. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
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 the study team for the most up-to-date information regarding possible participation.
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