Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2026-02-21 @ 4:09 AM
Study NCT ID:
NCT01688557
Status:
COMPLETED
Last Update Posted:
2016-10-07
First Post:
2012-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial on Innovative Technologies in Colonoscopy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011127', 'term': 'Polyps'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062048', 'term': 'Narrow Band Imaging'}], 'ancestors': [{'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-06', 'studyFirstSubmitDate': '2012-09-16', 'studyFirstSubmitQcDate': '2012-09-19', 'lastUpdatePostDateStruct': {'date': '2016-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Sensitivity of innovative colonoscopy', 'timeFrame': '1 year', 'description': 'The sensitivity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.'}, {'measure': 'Specificity of innovative colonoscopy', 'timeFrame': '1 year', 'description': 'The specificity of innovative colonoscopy will be assessed (in percentages) using StatSoft Statistica 10.0 software.'}, {'measure': 'Positive predictive Value (PPV) od innovative colonoscopy', 'timeFrame': '1 year', 'description': 'The positive predicting value of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.'}, {'measure': 'Negative predicting value (NPV) of innovative colonoscopy', 'timeFrame': '1 year', 'description': 'The negative predictive value (NPV) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.'}, {'measure': "Youden's index for innovative colonoscopy", 'timeFrame': '1 year', 'description': "The Youden's index of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software."}, {'measure': 'Diagnostic odds ratio (DOR) for innovative colonoscopy', 'timeFrame': '1 year', 'description': 'The diagnostic odds ratio (DOR) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.'}, {'measure': 'Likelihood ratio for positive test results (LR+)', 'timeFrame': '1 year', 'description': 'The likelihood ratio for positive test results of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.'}, {'measure': 'Likelihood ratio for negative test results (LR-)', 'timeFrame': '1 year', 'description': 'The likelihood ratio for negative test results (LR-) of innovative colonoscopy will be assessed using StatSoft Statistica 10.0 software.'}, {'measure': 'Area under the ROC curve (AUC)', 'timeFrame': '1 year', 'description': 'Area under the ROC curve for innovative colonoscopy will be calculated using StatSoft Statistica 10.0 software.'}], 'primaryOutcomes': [{'measure': 'Diagnostic accuracy of innovative colonoscopy', 'timeFrame': '1 year', 'description': 'Diagnostic accuracy of innovative techniques used during colonoscopy (narrow band imaging and double focus option) will be assessed using StatSoft Statistica 10.0 software. All lesions will be classified acc. to Sano and Kudo classification during colonoscopy and results will be compared with histologic examination.'}], 'secondaryOutcomes': [{'measure': 'Total examination time', 'timeFrame': '8-20 minutes', 'description': 'Time of the whole procedure (from insertion of the colonoscope to removing of the whole instrument) will be compared in conventional and innovative colonoscopy.'}, {'measure': 'Coecal intubation time', 'timeFrame': '5-15 minutes', 'description': 'Time from insertion of colonoscope to visualisation of the coecum - always confirmed by a snapshot.'}, {'measure': 'Pain intensity (VAS scale)', 'timeFrame': '0-10', 'description': 'Pain intensity will be assessed during and after each colonoscopy using the Visual Analogue Scale. It will be assessed immediately after colonoscopy, 15 min, 30 min, 1 hour and 2 hours after the procedure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['narrow band imaging', 'dual focus', 'responsive insertion technique', 'scope guide', 'colonoscopy', 'colorectal cancer screening'], 'conditions': ['Polyps', 'Neoplasms', 'Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '25840894', 'type': 'RESULT', 'citation': 'Szura M, Pasternak A, Bucki K, Urbanczyk K, Matyja A. Two-stage optical system for colorectal polyp assessments. Surg Endosc. 2016 Jan;30(1):204-14. doi: 10.1007/s00464-015-4186-x. Epub 2015 Apr 4.'}, {'pmid': '27631316', 'type': 'DERIVED', 'citation': 'Pasternak A, Szura M, Solecki R, Matyja M, Szczepanik A, Matyja A. Impact of responsive insertion technology (RIT) on reducing discomfort during colonoscopy: randomized clinical trial. Surg Endosc. 2017 May;31(5):2247-2254. doi: 10.1007/s00464-016-5226-x. Epub 2016 Sep 8.'}, {'pmid': '27572063', 'type': 'DERIVED', 'citation': 'Szura M, Pasternak A, Solecki R, Matyja M, Szczepanik A, Matyja A. Accuracy of preoperative tumor localization in large bowel using 3D magnetic endoscopic imaging: randomized clinical trial. Surg Endosc. 2017 May;31(5):2089-2095. doi: 10.1007/s00464-016-5203-4. Epub 2016 Aug 29.'}], 'seeAlsoLinks': [{'url': 'http://www.rydygier.cm-uj.krakow.pl/', 'label': 'The official site of the I Department of General Surgery, Jagiellonian University'}, {'url': 'http://www.medicina.pl', 'label': 'The official site of Specialist Diagnostic and Therapeutic Center MEDICINA'}]}, 'descriptionModule': {'briefSummary': 'The trial will compare results of screening colonoscopy performed by means of conventional colonoscopy and using new visualisation techniques during endoscopic examination.\n\n* Electronic colonoscopes Olympus CF-HQ190F with following options: magnetic positioning (Scope Guide), responsive insertion technology (RIT), dual focus function, narrow band imaging (NBI) will be used for innovative colonoscopies\n* Electronic colonoscopes Olympus CF-H180DL with Scope Guide and NBI options will be used for conventional colonoscopies Endoscopists will archive all images and establish presumptive diagnosis based on the results of different visualisation techniques. All endoscopes will be attached to Olympus Evis Exera III system. Biopsy of all pathological lesions will be performed to establish final diagnosis. The main outcome measure is diagnostic accuracy of innovative colonoscopy in comparison with conventional technique.', 'detailedDescription': 'A total of 600 consecutive patients undergoing screening unsedated colonoscopy will be randomly assigned to innovative or conventional examination. Randomization will be based on computer-generated randomization lists. All patients will be blinded so they will not know which techniques will be used to assess lesions found in colon. In innovative colonoscopy group narrow band imaging (NBI) and Dual Focus (DF) function will be used to identify and classify all lesions acc. to Sano and Kudo classification. Endoscopic biopsy will be taken from all lesion and endoscopic diagnosis will be compared with final histological diagnosis. Thus sensitivity, specificity, diagnostic accuracy, predictive values, likelihood ratio and Youden index will be calculated. As secondary endpoints total examination time, coecal intubation rate and pain intensity (VAS scale) will be established. This study will help to establish whether new technologies used during colonoscopy may improve diagnostic possibilities and whether they prolong examination time or lead to increase of pain intensity afterwards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* written informed consent\n* no previous abdominal surgery\n* no colonoscopy during last 10 years\n\nExclusion Criteria:\n\n* age \\< 40 and \\> 65 years\n* large bowel resection in history\n* colonoscopy performed during last 10 years\n* contraindications for general anaesthesia\n* ASA \\> IV\n* pregnancy\n* confirmed neoplastic disease\n* cirrhosis (Child B or C) or ascites\n* immunosuppressive therapy or steroids intake\n* malabsorption syndrome'}, 'identificationModule': {'nctId': 'NCT01688557', 'acronym': 'RCT-IC', 'briefTitle': 'Trial on Innovative Technologies in Colonoscopy', 'organization': {'class': 'OTHER', 'fullName': 'Jagiellonian University'}, 'officialTitle': 'Prospective Randomised Trial Comparing New Technologies of Endoscopic Bowel Visualisation With Conventional Colonoscopy.', 'orgStudyIdInfo': {'id': 'Innovations in colonoscopy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Innovative colonoscopy', 'description': 'Innovative colonoscopy performed using narrow band imaging and dual focus function (NBI + Dual Focus).', 'interventionNames': ['Device: Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional colonoscopy', 'description': 'Conventional colonoscopy performed without innovative techniques assessed in this study.', 'interventionNames': ['Device: Conventional colonoscopy (Olympus CF-H180DL)']}], 'interventions': [{'name': 'Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)', 'type': 'DEVICE', 'description': 'NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.', 'armGroupLabels': ['Innovative colonoscopy']}, {'name': 'Conventional colonoscopy (Olympus CF-H180DL)', 'type': 'DEVICE', 'description': 'Conventional colonoscopy performed without innovative techniques used in experimental arm.', 'armGroupLabels': ['Conventional colonoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30-307', 'city': 'Krakow', 'state': 'Malopolska', 'country': 'Poland', 'facility': 'Specialist Diagnostic and Therapeutic Center MEDICINA', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}, {'zip': '31-501', 'city': 'Krakow', 'state': 'Malopolska', 'country': 'Poland', 'facility': 'I Department of General Surgery, Jagiellonian University', 'geoPoint': {'lat': 50.06143, 'lon': 19.93658}}], 'overallOfficials': [{'name': 'Miroslaw Szura, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'I Department of General Surgery, Jagiellonian University'}, {'name': 'Radoslaw Pach, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'I Department of General Surgery, Jagiellonian University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jagiellonian University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Specialist Diagnostic and Therapeutic Center MEDICINA', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assisstant Professor', 'investigatorFullName': 'Miroslaw Szura', 'investigatorAffiliation': 'Jagiellonian University'}}}}