Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-01-21 @ 10:39 PM
Study NCT ID:
NCT02166320
Status:
COMPLETED
Last Update Posted:
2017-01-05
First Post:
2014-06-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-04', 'studyFirstSubmitDate': '2014-06-16', 'studyFirstSubmitQcDate': '2014-06-16', 'lastUpdatePostDateStruct': {'date': '2017-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-06-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'SEMS dislocation in cm during first thirty days after stent insertion.', 'timeFrame': 'Thirty days from stent deployment.'}], 'secondaryOutcomes': [{'measure': 'Health Related Quality of Life (HRQOL)', 'timeFrame': 'Within three months of SEMS deployment.'}, {'measure': 'Need for reintervention', 'timeFrame': 'Within three months after SEMS'}, {'measure': 'Grade of dysphagia within three months of SEMS.', 'timeFrame': 'Three months after insertion.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Esophageal Cancer', 'Cancer of Gastro Esophageal Junction', 'Palliative Treatment']}, 'descriptionModule': {'briefSummary': 'Self expandable stent (SEMS) constitutes the main palliative treatment in advanced esophageal cancer. The palliative effect of SEMS is immediate when it comes to relief of dysphagia. The duration of this effect is however questionable. The design of SEMS can be of importance since the device can dislodge and as a consequence of that dysphagia recur. The hypothesis has therefore been formulated that a partially covered SEMS is associated with less tendency to dislocate as compared to those SEMS, recently developed, which are covered through their entire length.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Verified Squamous Cell Carcinoma or Adenocarcinoma of esophagus or Gastro Esophageal Junction (GEJ)\n* Age above 18 years.\n* Dysphagia scoring grade two or worse\n* Not amenable for curative treatment\n* Informed consent to participate\n\nExclusion Criteria:\n\n* Concomitant cancer disease\n* Inability to comply with study protocol\n* Previous stent treatment\n* Proximal location of the tumour in the esophagus.\n* Need for more than one stent deployment.'}, 'identificationModule': {'nctId': 'NCT02166320', 'acronym': 'StentMig', 'briefTitle': 'Treatment of Malignant Strictures in Esophagus and Gastroesophageal Junction With Covered or Partially Covered Stent.', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska University Hospital'}, 'officialTitle': 'The Importance of Stent Design', 'orgStudyIdInfo': {'id': '2009/1034-31/3'}, 'secondaryIdInfos': [{'id': '2009/1034-31/3', 'type': 'OTHER', 'domain': 'Ethical Review board, Karolinska Institute Stockholm'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Partially covered SEMS', 'description': 'Boston Scientific Ultraflex SEMS', 'interventionNames': ['Device: Partially covered SEMS']}, {'type': 'EXPERIMENTAL', 'label': 'Fully covered SEMS', 'description': 'Boston Scientific Wallflex Esophageal SEMS.', 'interventionNames': ['Device: Fully covered SEMS']}], 'interventions': [{'name': 'Partially covered SEMS', 'type': 'DEVICE', 'armGroupLabels': ['Partially covered SEMS']}, {'name': 'Fully covered SEMS', 'type': 'DEVICE', 'armGroupLabels': ['Fully covered SEMS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41345', 'city': 'Gothenburg', 'country': 'Sweden', 'facility': 'Erik Johnsson', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Erik Johnsson, MdPhd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sahlgrenska University Hospital, Clinic of Surgery'}, {'name': 'Magnus Nilsson, ass professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}, {'name': 'Blekinge County Council Hospital', 'class': 'OTHER'}, {'name': 'Danderyd Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lars Lundell', 'investigatorAffiliation': 'Karolinska University Hospital'}}}}