Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2026-01-02 @ 10:51 AM
Study NCT ID:
NCT03438695
Status:
UNKNOWN
Last Update Posted:
2018-02-20
First Post:
2018-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Total Motorized Spiral Enteroscopy Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-02-21', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-02-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-13', 'studyFirstSubmitDate': '2018-02-13', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of total enteroscopy by Motorized Spiral Enteroscopy', 'timeFrame': '2 days', 'description': 'Total enteroscopy by:\n\n1. a complete anterograde approach\n2. or a combined anterograde and retrograde approach'}], 'secondaryOutcomes': [{'measure': 'Procedural Success Rate', 'timeFrame': '2 days', 'description': 'of anterograde and retrograde approach'}, {'measure': 'Procedural time', 'timeFrame': '2 days', 'description': 'of anterograde and retrograde approach'}, {'measure': 'Depth of maximum insertion to the small bowel', 'timeFrame': '2 days', 'description': 'anterograde and retrograde'}, {'measure': 'Diagnostic yield', 'timeFrame': '2 days', 'description': 'anterograde and retrograde'}, {'measure': 'Therapeutic yield', 'timeFrame': '2 days', 'description': 'anterograde and retrograde'}, {'measure': 'Adverse events', 'timeFrame': '3 days', 'description': 'anterograde and retrograde, serious adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['endoscopy, motorized spiral enteroscopy'], 'conditions': ['Small Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '33144239', 'type': 'DERIVED', 'citation': 'Beyna T, Arvanitakis M, Schneider M, Gerges C, Hoellerich J, Deviere J, Neuhaus H. Total motorized spiral enteroscopy: first prospective clinical feasibility trial. Gastrointest Endosc. 2021 Jun;93(6):1362-1370. doi: 10.1016/j.gie.2020.10.028. Epub 2020 Nov 2.'}]}, 'descriptionModule': {'briefSummary': 'Study design Prospective bicentric non-controlled clinical trial\n\nStudy purpose\n\n\\- to evaluate the efficacy and safety of Novel Motorized Spiral Enteroscopy (NMSE) for total enteroscopy in patients with suspected small bowel diseases with an indication for direct visualization of the entire small bowel\n\nPrimary objective\n\nRate of total enteroscopy by means of NMSE with:\n\n1. a complete anterograde approach\n2. or a combined anterograde and retrograde approach\n\nSecondary objectives\n\n* Procedural success of anterograde and retrograde approach\n* Procedural time (minutes)\n* Depth of maximum insertion (cm)\n* Diagnostic yield\n* Therapeutic yield\n* Adverse events'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients with small bowel disease with an indication for a total enteroscopy, e.g.:\n* Overt obscure gastrointestinal bleeding or obscure gastrointestinal bleeding or indeterminate iron-deficiency anaemia and positive Video capsule endoscopy (VCE) or negative VCE in patients who have ongoing bleeding shown by overt bleeding or continued need for blood transfusions\n* Abdominal pain or chronic diarrhoea with positive findings of small bowel imaging examinations\n* Noncontributory ileocolonoscopy and suspicion of Crohn's disease on small-bowel cross-sectional imaging modalities or small-bowel capsule endoscopy\n* Further evaluation of known Crohn's disease or therapeutic indications in Crohn's disease\n* Large polyps (\\>10-15mm) in the jejunum and ileum discovered by radiological examination or small-bowel capsule endoscopy in patients with Peutz-Jeghers syndrome\n* Nonresponsive or refractory coeliac disease\n\nExclusion Criteria:\n\n* \\- Age under 18 years\n* Health status American Society of Anesthesists Classification (ASA) 4\n* Pregnancy\n* Coagulopathy (INR≥2.0, Platelets \\< 70/nl)\n* Taking anti-platelet agents or anticoagulants (other than aspirin) within last 7 days\n* Any medical contraindication to standard enteroscopy\n* Presence of any intraluminal or extraluminal foreign body in the abdominal cavity\n* Any prior gastric, small bowel or colonic surgery, or implantable devices in these locations (cardiac pacemakers and non-abdominal implants are acceptable)\n* Known or suspected bowel obstruction or stenosis or history of bowel obstruction\n* Known coagulation disorder\n* Known or suspected esophageal stricture or Schatzki ring\n* Known gastric or esophageal varices\n* Suspected perforation of the GI tract\n* Known or suspected colonic or ileocecal valve (ICV) stricture\n* Inability to tolerate sedation or general anesthesia for any reason\n* Inability to tolerate endotracheal intubation\n* Absence of a signed informed consent"}, 'identificationModule': {'nctId': 'NCT03438695', 'acronym': 'TMSET', 'briefTitle': 'Total Motorized Spiral Enteroscopy Trial', 'organization': {'class': 'OTHER', 'fullName': 'Evangelisches Krankenhaus Düsseldorf'}, 'officialTitle': 'Total Motorized Spiral Enteroscopy Trial', 'orgStudyIdInfo': {'id': 'TMSET 1.0'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Motorized Spiral Enteroscopy', 'description': 'Patients with indication for total enteroscopy. day1: anterograde motorized spiral enteroscopy, day 2: retrograde motorized spiral enteroscopy', 'interventionNames': ['Procedure: Motorized Spiral Enteroscopy']}], 'interventions': [{'name': 'Motorized Spiral Enteroscopy', 'type': 'PROCEDURE', 'description': 'Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, After reaching the cecum or if no further advancement of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. If no total enteroscopy was achieved, a submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde peranal enteroscopy is then performed on one of the following days.', 'armGroupLabels': ['Motorized Spiral Enteroscopy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Torsten Beyna, MD', 'role': 'CONTACT', 'email': 'torsten.beyna@evk-duesseldorf.de', 'phone': '+49-211-9191605'}, {'name': 'Horst Neuhaus, MD, PhD', 'role': 'CONTACT', 'email': 'horst.neuhaus@evk-duesseldorf.de', 'phone': '+49-211-9191605'}], 'overallOfficials': [{'name': 'Torsten Beyna, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'EVK Düsseldorf, Germany'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Evangelisches Krankenhaus Düsseldorf', 'class': 'OTHER'}, 'collaborators': [{'name': 'Université Libre de Bruxelles', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}