Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-24 @ 5:45 AM
Study NCT ID:
NCT02030756
Status:
COMPLETED
Last Update Posted:
2017-11-07
First Post:
2014-01-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003248', 'term': 'Constipation'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 144}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'dispFirstSubmitDate': '2017-10-31', 'completionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-05', 'studyFirstSubmitDate': '2014-01-07', 'dispFirstSubmitQcDate': '2017-10-31', 'studyFirstSubmitQcDate': '2014-01-07', 'dispFirstPostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of bowel movements', 'timeFrame': '3 months', 'description': 'change from baseline in the weekly Spontaneous Bowel Movement (SBM) rate during treatment period. Success will be defined as increase by at least 1 SBM/week. The primary analysis will be a comparative analysis of success rates between the study groups'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['constipation'], 'conditions': ['Chronic Idiopathic Constipation']}, 'descriptionModule': {'briefSummary': 'This is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving Constipated Individuals'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients aged 18 years and older.\n2. Patients with chronic idiopathic constipation according to Rome III criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose).\n3. Patients with more than 1 bowel movement/2 weeks and \\< 3 bowel movement/week.\n4. Colonoscopy performed in the past 10 years prior to study participation, unless the patients are \\<50 years old and without alarming signs and symptoms\n5. Patient signed ICF\n6. For women with childbearing potential, adequate contraception\n\nExclusion Criteria:\n\n1. History of complicated/obstructive diverticular disease\n2. History of intestinal or colonic obstruction.\n3. History of significant GI disorder.\n4. 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\n5. Clinical evidence of significant respiratory, CVS, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers.\n6. Presence of pacemaker.\n7. History of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating.\n8. 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 GI resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia.\n9. History of Zenker's diverticulum, dysphagia or a known esophageal stricture 10. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)\n\n11\\. Participation in another clinical study in the last 4 months prior to screening.\n\n12\\. 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.\n\n13\\. Women who are pregnant or lactating.\n\n\\-"}, 'identificationModule': {'nctId': 'NCT02030756', 'briefTitle': 'Performance, Efficacy and Safety of Vibrating Capsule in Aiding Constipated Individuals', 'organization': {'class': 'INDUSTRY', 'fullName': 'Vibrant Ltd.'}, 'officialTitle': 'Assessment of the Performance, Efficacy and Safety of Vibrating Capsule Medical Device in Aiding Reliving Constipated Individuals.', 'orgStudyIdInfo': {'id': 'Vibrant-14-MS-CTIL'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Vibrating capsule', 'description': 'patients will receive vibrating capsule for 8 weeks of treatment \\[1 every 3 days (+/- 1 day)\\].', 'interventionNames': ['Device: vibrating capsule']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham non-vibrating capsule', 'description': 'patients will receive sham non-vibrating capsule for 8 weeks of treatment \\[1 every 3 days (+/- 1 day)\\].', 'interventionNames': ['Device: sham non-vibrating capsule']}], 'interventions': [{'name': 'vibrating capsule', 'type': 'DEVICE', 'description': 'patients will receive vibrating capsule for 8 weeks of treatment \\[1 every 3 days (+/- 1 day)\\].', 'armGroupLabels': ['Vibrating capsule']}, {'name': 'sham non-vibrating capsule', 'type': 'DEVICE', 'description': 'patients will receive sham non-vibrating capsule for 8 weeks of treatment \\[1 every 3 days (+/- 1 day)\\].', 'armGroupLabels': ['sham non-vibrating capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32256', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Borland-Groover Clinic', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30912', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Regents University', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'MGG Group Co., Inc., Chevy Chase Clinical Research', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Mgh Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Hospital', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Albuquerque Neuroscience', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University School of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15206', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'CTRS LLC', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Huoston Methodist Hosptial', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Bat Yam', 'country': 'Israel', 'facility': 'Bat-Yamon', 'geoPoint': {'lat': 32.02379, 'lon': 34.75185}}, {'city': 'Hadera', 'country': 'Israel', 'facility': 'Degani center Clalit MC', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}, {'city': 'Herzliya', 'country': 'Israel', 'facility': 'Expert clinic Clalit MC', 'geoPoint': {'lat': 32.16627, 'lon': 34.82536}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Talpiot clinic Clalit MC', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Kiryat Bialik', 'country': 'Israel', 'facility': 'Zvoulon MC Clalit MC', 'geoPoint': {'lat': 32.8275, 'lon': 35.08583}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': '100 Tower', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Souraski Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vibrant Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}