Ignite Creation Date:
2025-12-24 @ 7:07 PM
Ignite Modification Date:
2026-01-02 @ 8:05 AM
Study NCT ID:
NCT07026357
Status:
COMPLETED
Last Update Posted:
2025-06-18
First Post:
2022-06-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-15', 'studyFirstSubmitDate': '2022-06-07', 'studyFirstSubmitQcDate': '2025-06-15', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endoscopic therapy success', 'timeFrame': '3 months after intervention at endoscopic control examination', 'description': 'Change in esophageal diameter \\[mm\\] and length of esophageal stricture \\[cm\\] after endoscopic therapy'}], 'secondaryOutcomes': [{'measure': 'Length measurement of esophageal stenosis', 'timeFrame': 'during endoscopic intervention', 'description': 'Length measurement of esophageal stenosis by different methods \\[cm\\]'}, {'measure': 'Postinterventional esophageal diameter', 'timeFrame': 'directly after endoscopic intervention', 'description': 'Postinterventional esophageal diameter \\[mm\\]'}, {'measure': 'Hospitalization time after endoscopic dilatation therapy', 'timeFrame': 'within 3 months after study intervention', 'description': 'Period of Hospitalization \\[days\\] after endoscopic dilatation therapy'}, {'measure': 'Number of endoscopic interventions', 'timeFrame': 'within 3 months after study intervention', 'description': 'Number of endoscopic interventions after study intervention'}, {'measure': 'Number of hospitalizations due to complications', 'timeFrame': 'within 3 months after initial study intervention', 'description': 'Hospitalization after study intervention \\[number of events, days\\] due to complications'}, {'measure': 'Quality of life assessed by German Sydney Swallow Questionnaire', 'timeFrame': 'Baseline study intervention and 2 weeks after study intervention', 'description': 'Quality of life according to the German Sydney Swallow Questionnaire (G-SWAL-QoL) questionnaire \\[17 questions, minimum 0 to maximum 1700 points; higher score indicates higher impairment considering swallowing\\]'}, {'measure': 'Complication rate', 'timeFrame': 'during the procedure', 'description': 'Peri-procedural complication rate'}, {'measure': 'Duration of endoscopic examination', 'timeFrame': 'during the procedure', 'description': 'Duration of endoscopic examination \\[minutes\\]'}, {'measure': 'Sedation dose', 'timeFrame': 'during the procedure', 'description': 'Dose of sedative medication \\[mg\\] during study intervention'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Benign Esophageal Stricture']}, 'descriptionModule': {'briefSummary': 'Esophageal stenosis has a high impact on patients quality of live and food intake affecting personal nutrition status and general health.\n\nFor benign strictures of the esophagus, endoscopic dilatation therapy is recommended by actual guidelines.\n\nSince the extent of dilatation is currently directed by endoscopic view and fluoroscopic imaging, patients are exposed to radiation and the determination of the appropriate extent of dilatation is difficult.\n\nTherefore, the aim of this study is to compare the effect of 3D-planimetric measurement with current fluoroscopic monitoring on the success of endoscopic esophageal dilatation therapy in patients with benign esophageal stenosis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* symptomatic benign esophageal stenosis\n* medical indication for endoscopic therapy\n* written consent after detailed information\n\nExclusion Criteria:\n\n* non-benign esophageal stenosis\n* missing written consent\n* trans-oral endoscopic access is not possible\n* medical contraindication for endoscopic dilatation therapy\n* age \\<18 years'}, 'identificationModule': {'nctId': 'NCT07026357', 'acronym': 'INTENSE', 'briefTitle': 'Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Ulm'}, 'officialTitle': 'Impact of 3D-planimetry on Optimized Therapeutic Assessment in Complex Benign Esophageal Stenosis; a Prospective Multi-center Study', 'orgStudyIdInfo': {'id': 'UL001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '3D-planimetric Measurement', 'description': 'Esophageal stenosis is measured and endoscopic therapy is controlled by 3D-planimetry in addition to the conventional method (fluoroscopy, endoscopic examination)', 'interventionNames': ['Device: 3D-planimetric measurement', 'Radiation: Fluoroscopic control', 'Diagnostic Test: Endoscopic control']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional Measurement', 'description': 'Esophageal stenosis is measured and endoscopic therapy is controlled by fluoroscopy and endoscopic examination only', 'interventionNames': ['Radiation: Fluoroscopic control', 'Diagnostic Test: Endoscopic control']}], 'interventions': [{'name': '3D-planimetric measurement', 'type': 'DEVICE', 'description': 'Esophageal stenosis is evaluated by 3D-planimetric measurement', 'armGroupLabels': ['3D-planimetric Measurement']}, {'name': 'Fluoroscopic control', 'type': 'RADIATION', 'description': 'Fluoroscopic control of dilatation therapy', 'armGroupLabels': ['3D-planimetric Measurement', 'Conventional Measurement']}, {'name': 'Endoscopic control', 'type': 'DIAGNOSTIC_TEST', 'description': 'Macroscopic endoscopic control of dilatation therapy', 'armGroupLabels': ['3D-planimetric Measurement', 'Conventional Measurement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '89081', 'city': 'Ulm', 'state': 'Baden-Wuerttenberg', 'country': 'Germany', 'facility': 'University Hospital Ulm, Clinic for Internal Medicine I', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}], 'overallOfficials': [{'name': 'Benjamin Walter, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Ulm'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Seufferlein', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, {'name': 'University Hospital Augsburg', 'class': 'OTHER'}, {'name': 'University Hospital Munich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr.', 'investigatorFullName': 'Thomas Seufferlein', 'investigatorAffiliation': 'University of Ulm'}}}}