Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2026-02-21 @ 11:18 PM
Study NCT ID:
NCT05140057
Status:
UNKNOWN
Last Update Posted:
2021-12-01
First Post:
2021-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C520497', 'term': 'MoviPrep'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 210}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-17', 'studyFirstSubmitDate': '2021-10-05', 'studyFirstSubmitQcDate': '2021-11-17', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic yield', 'timeFrame': 'During the procedure', 'description': 'Proportion of SBCE with positive findings. findings will be classified based on the Saurin classification; the investigators will consider a positive SBCE when lesions classified as P2 or active bleeding are detected (Saurin classification, Table 2), the remaining will be classified as negative'}, {'measure': 'Adequate cleansing rate', 'timeFrame': 'During the procedure', 'description': 'A cutoff value of quantitative index ≥ 8 points'}], 'secondaryOutcomes': [{'measure': 'Proportion of SBCE with vascular lesions', 'timeFrame': 'During the procedure', 'description': 'Vascular lesions identified in each tertile'}, {'measure': 'Proportion of SBCE with active bleeding', 'timeFrame': 'During the procedure', 'description': 'Active bleeding in each tertile'}, {'measure': 'Diagnostic yield per tertile', 'timeFrame': 'During the procedure', 'description': 'Positive findings in each tertile'}, {'measure': 'Transit times', 'timeFrame': 'During the procedure', 'description': 'Time of entry in the stomach, duodenum and cecum'}, {'measure': 'Symptoms experienced during SBCE procedure', 'timeFrame': 'During the procedure', 'description': 'Nausea, vomit, bloating, abdominal pain'}, {'measure': "Overall patients' satisfaction with the cleansing regimen", 'timeFrame': 'During the procedure', 'description': 'rated on a 5-point scale: 1 - very easy, 2 - easy, 3 - intermediate, 4 - difficult, 5 - very difficult'}, {'measure': 'Small bowel cleansing', 'timeFrame': 'During the procedure', 'description': 'Mean quantitative index of the distal third of small bowel'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Small bowel capsule endoscopy', 'Obscure gastrointestinal bleeding', 'Bowel preparation'], 'conditions': ['Obscure Gastrointestinal Bleeding']}, 'descriptionModule': {'briefSummary': "Small bowel capsule endoscopy (SBCE) has become an important tool in clinical practice since its introduction in 2000. This non-invasive method allows the visualization of small bowel mucosa, being essential in the management of many conditions, such as suspected small bowel bleeding, inflammatory bowel diseases and intestinal polyposis syndromes. Despite recommendations concerning SBCE in different pathologies, there are still some technical concerns to be addressed. The optimal preparation for SBCE has been one of these controversial issues.\n\nCurrently, the European Society of Gastrointestinal Endoscopy (ESGE) recommends that patients ingest a purgative agent (2L of polyethylene glycol, PEG) and antifoaming agents for SBCE, because it was associated with a better visualization. However, it remains unclear which is the optimal timing for purgative use. Furthermore, the use of a booster agent after capsule ingestion is already performed in colon capsule endoscopy, but less is known about its application in SBCE. Also, it remains to be clarified whether a better visualization results in higher diagnostic yield and impacts patients' outcomes.\n\nTherefore, the global aim of this prospective, randomized, multi-centric study is to determine the optimal timing and preparation for small-bowel capsule endoscopy (regardless of the equipment used), comparing four groups of different preparation protocols:\n\n* Protocol 1) 1L of Moviprep® solution the night before the procedure\n* Protocol 2) 1L of Moviprep® solution up to 2h before the procedure\n* Protocol 3) 0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum (assessed with real-time viewer)\n* Protocol 4) 1L of Moviprep® solution after the capsule had reached the duodenum (assessed using real-time viewer)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be 18 years old or older\n* Present OGIB (either occult or overt)\n* Agree with study\'s procedures and have signed the informed consent for the study and SBCE, prior to SBCE procedure\n\nExclusion Criteria:\n\n* Patients performing capsule endoscopy in urgent setting for overt obscure GI bleeding\n* Inpatients or bedridden\n* History of surgery of the esophagus, stomach, small bowel, or colon\n* History of abdominal or pelvic radiation therapy\n* Suspected or confirmed stenosis or occlusion\n* Suspected or confirmed bowel perforation\n* Severe comorbidities, as defined by grade 3 "severe decompensation" in the Adult Comorbidity Evaluation-27 index (ACE-27)\n* Pregnant women\n* Patients using narcotics or prokinetics in the week before the SBCE'}, 'identificationModule': {'nctId': 'NCT05140057', 'acronym': 'PrepRICE', 'briefTitle': 'Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.'}, 'officialTitle': 'Preparation Regimens to Improve Capsule Endoscopy Visualization and Diagnostic Yield: a Randomized Trial', 'orgStudyIdInfo': {'id': '0001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protocol 1', 'description': '1L of Moviprep® solution the night before the procedure', 'interventionNames': ['Combination Product: Moviprep']}, {'type': 'EXPERIMENTAL', 'label': 'Protocol 2', 'description': '1L of Moviprep® solution up to 2h before the procedure', 'interventionNames': ['Combination Product: Moviprep']}, {'type': 'EXPERIMENTAL', 'label': 'Protocol 3', 'description': '0.5L of Moviprep® solution up to 2h before the procedure plus 0.5L of Moviprep® solution after the capsule had reached the duodenum', 'interventionNames': ['Combination Product: Moviprep']}, {'type': 'EXPERIMENTAL', 'label': 'Protocol 4', 'description': '1L of Moviprep® solution after the capsule had reached the duodenum', 'interventionNames': ['Combination Product: Moviprep']}], 'interventions': [{'name': 'Moviprep', 'type': 'COMBINATION_PRODUCT', 'description': 'Bowel preparation for small bowel capsule endoscopy - same product for all groups, different administration timings', 'armGroupLabels': ['Protocol 1', 'Protocol 2', 'Protocol 3', 'Protocol 4']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Vila Nova de Gaia', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Manuela Estevinho', 'role': 'CONTACT', 'email': 'mmestevinho@gmail.com', 'phone': '+351 227865100'}, {'name': 'Rolando Pinho', 'role': 'CONTACT'}, {'name': 'Rolando Pinho', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana Catarina Gomes', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ana Ponte', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Adélia Rodrigues', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manuela Estevinho', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Gastroenterology, Centro Hospitalar Vila Nova de Gaia/Espinho', 'geoPoint': {'lat': 41.12401, 'lon': -8.61241}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor, Principal Investigator', 'investigatorFullName': 'Maria Manuela Estevinho', 'investigatorAffiliation': 'Centro Hospitalar de Vila Nova de Gaia/Espinho, E.P.E.'}}}}