Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-25 @ 8:23 PM
Study NCT ID:
NCT00225069
Status:
COMPLETED
Last Update Posted:
2012-08-23
First Post:
2005-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracoscopic Sympathectomy for Blushing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-22', 'studyFirstSubmitDate': '2005-09-21', 'studyFirstSubmitQcDate': '2005-09-21', 'lastUpdatePostDateStruct': {'date': '2012-08-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of operation. Side effects: compensatory and gustatory sweating.', 'timeFrame': '12 months after surgery'}]}, 'conditionsModule': {'keywords': ['Facial blushing', 'Sympathectomy'], 'conditions': ['Facial Blushing']}, 'descriptionModule': {'briefSummary': 'To determine outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing and investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy.', 'detailedDescription': 'To determine the outcome and side effects following thoracoscopic sympathectomy in patients treated for disabling isolated facial blushing. In addition, following randomization investigate if there are any significant differences between two different routine procedures: T2 or T2-T3 sympathectomy. Includes QoL before and 12 months after surgery'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Isolated disabling facial blushing\n* Over 18 years of age\n* Willing to be randomized\n\nExclusion Criteria:\n\n* Primary hyperhidrosis in palms or axillae\n* Previous lung surgery\n* Bradycardia\n* Arrythmias\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT00225069', 'briefTitle': 'Thoracoscopic Sympathectomy for Blushing', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Thoracoscopic Sympathectomy for Blushing. A Prospective Randomised Trial.', 'orgStudyIdInfo': {'id': 'TOPSY1-2005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'T2 sympathectomy', 'interventionNames': ['Procedure: Level of sympathectomy']}, {'type': 'EXPERIMENTAL', 'label': '2', 'description': 'T2-T3 sympathectomy', 'interventionNames': ['Procedure: Level of sympathectomy']}], 'interventions': [{'name': 'Level of sympathectomy', 'type': 'PROCEDURE', 'description': 'T2 sympathectomy or T2-T3 sympathectomy', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Dept Cardiothoracic Surgery, Skejby Sygehus, Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}, {'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Dept Cardiothorcic Surgery, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Peter B Licht, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}, {'name': 'Hans K Pilegaard, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Skejby Sygehus, Aarhus University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Peter B Licht', 'investigatorAffiliation': 'Odense University Hospital'}}}}