Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-01-01 @ 10:36 AM
Study NCT ID:
NCT02387268
Status:
COMPLETED
Last Update Posted:
2017-09-20
First Post:
2015-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of the Performance of the CleanC System-Israel
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kobiedi@clalit.org.il', 'phone': '048250055', 'title': 'Dr.Kobie Dickstein', 'organization': 'M.C.Carmel'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'CleanC', 'description': 'Standard colonoscopy procedure using the CleanC system\n\nCleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure', 'otherNumAtRisk': 10, 'otherNumAffected': 1, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Mild abdominal pain', 'notes': 'Mild abdominal pain was reports as probably related to colonoscopy procedure and not to Motus GI CleanC system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CleanC', 'description': 'Standard colonoscopy procedure using the CleanC system\n\nCleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.7', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the colonoscopy procedure withdrawal phase (10 min in average)', 'description': 'Scale ranges- Min-0, Max-3 where:\n\n0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.\n\n1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.\n2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.\n3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Safety as Measured by Number of Serious Adverse Events and Major Complications.', 'timeFrame': 'Max of 9 days', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants in Whom the Cecum Was Reached', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CleanC', 'description': 'Standard colonoscopy procedure using the CleanC system\n\nCleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure'}], 'classes': [{'categories': [{'measurements': [{'value': '88.9', 'groupId': 'OG000', 'lowerLimit': '51.7', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During the colonoscopy procedure', 'description': 'A procedure was considered complete when the cecum was reached and visualized.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CleanC', 'description': 'Standard colonoscopy procedure using the CleanC system\n\nCleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CleanC', 'description': 'Standard colonoscopy procedure using the CleanC system\n\nCleanC system: Cleansing liquid and fecal matter during a standard colonoscopy procedure'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Israel', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-22', 'studyFirstSubmitDate': '2015-03-02', 'resultsFirstSubmitDate': '2015-10-06', 'studyFirstSubmitQcDate': '2015-03-08', 'lastUpdatePostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-08', 'studyFirstPostDateStruct': {'date': '2015-03-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Subjects With Post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS) Adequate Cleansing-(BBPS>1 )', 'timeFrame': 'During the colonoscopy procedure withdrawal phase (10 min in average)', 'description': 'Scale ranges- Min-0, Max-3 where:\n\n0 = Unprepared colon segment with mucosa not seen due to solid stool that cannot be cleared.\n\n1. = Portion of mucosa of the colon segment seen, but other areas of the colon segment not well seen due to staining, residual stool and/or opaque liquid.\n2. = Minor amount of residual staining, small fragments of stool and/or opaque liquid, but mucosa of colon segment seen well.\n3. = Entire mucosa of colon segment seen well with no residual staining, small fragments of stool or opaque liquid. The wording of the scale was finalized after incorporating feedback from three colleagues experienced in colonoscopy.'}, {'measure': 'Safety as Measured by Number of Serious Adverse Events and Major Complications.', 'timeFrame': 'Max of 9 days'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants in Whom the Cecum Was Reached', 'timeFrame': 'During the colonoscopy procedure', 'description': 'A procedure was considered complete when the cecum was reached and visualized.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer (CRC) Screening']}, 'descriptionModule': {'briefSummary': 'The Motus GI Colon Cleansing device is intended to facilitate intra-procedural cleaning of a poorly prepared colon by irrigating the colon and evacuating the irrigation fluid and feces.', 'detailedDescription': 'The study aim to evaluate the post Procedure Cleansing Level as Measured by the Boston Bowel Preparation Scale (BBPS).\n\nEach subject was required to follow a bowel preparation regimen including split dose of 2 tablets of 5mg Bysacodyle followed by a colonoscopy procedure with the tested device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects in the age range of 18-75 years\n2. Subjects with BMI within the range of 18.5-35\n3. Subject is willing to sign informed consent form\n\nExclusion Criteria:\n\n1. Active or severe inflammatory bowel disease (IBD)\n2. Subjects with severe diverticulitis \\\\ diverticular disease (known or detected)\n3. Known or detected colonic stenosis\n4. Known or detected bowel obstruction\n5. History of prior colon surgery\n6. ASA≥IV (sever systemic disease)\n7. Sever Renal insufficiency (Creatinine≥1.5mg%)\n8. Sever Liver insufficiency (ALT/AST≥2UNL)\n9. Contraindication for "colonoscopy" anesthesia \\\\ sedation \\\\ prep agent\n10. pregnancy\n11. Subjects with altered mental status/inability to provide informed consent\n12. Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly'}, 'identificationModule': {'nctId': 'NCT02387268', 'briefTitle': 'Evaluation of the Performance of the CleanC System-Israel', 'organization': {'class': 'INDUSTRY', 'fullName': 'Motus GI Medical Technologies Ltd'}, 'officialTitle': 'Evaluation of the Performance of the "CleanC" System', 'orgStudyIdInfo': {'id': 'CL00005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CleanC', 'description': 'Standard colonoscopy procedure using the CleanC system', 'interventionNames': ['Device: CleanC system']}], 'interventions': [{'name': 'CleanC system', 'type': 'DEVICE', 'description': 'Cleansing liquid and fecal matter during a standard colonoscopy procedure', 'armGroupLabels': ['CleanC']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'De-identified individual participant for primary and secondary outcome measures may be become available in the future'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Motus GI Medical Technologies Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}