Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-03 @ 6:46 PM
Study NCT ID:
NCT01259960
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2010-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-21', 'studyFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2010-12-14', 'lastUpdatePostDateStruct': {'date': '2017-09-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-12-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Operation related complications', 'timeFrame': 'between operation and hospital discharge of patient'}, {'measure': 'Post operative fever', 'timeFrame': 'between operation and hospital discharge of patient'}, {'measure': 'Liquor leakage', 'timeFrame': 'between operation and hosital discharge of patient'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Degenerative Lumbar Disease']}, 'descriptionModule': {'briefSummary': 'Being confronted more and more with obese as well as older patients, minimally invasive surgery is said to keep the surgical trauma low. The prospective long-term evaluation is the continuous monitoring of patients undergoing lumbar minimally invasive fusion surgery and analyzing the effect of body mass index (BMI) and wound healing.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All patients who will undergo minimal access surgical technige for degenerative lumbar disease fusion', 'healthyVolunteers': False, 'eligibilityCriteria': '* All patients who will undergo minimally access surgical technique for degenerative lumbar disease fusion surger\n* Patient willing to participate in observational study and who signs patient information and patient consent form\n* patient older that 18 years\n* all products will be used within intended use'}, 'identificationModule': {'nctId': 'NCT01259960', 'briefTitle': 'Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation', 'organization': {'class': 'OTHER', 'fullName': 'General Hospital Amstetten'}, 'officialTitle': 'Minimal Access Surgical Technique (MAST) in Obese Patients in Degenerative Lumbar Disease. A Prospective Long-term Evaluation.', 'orgStudyIdInfo': {'id': '2-Senker'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'BMI < 25', 'description': "Body Mass Index (BMI) according to WHO definition. BMI \\< 25 is defined as 'normal weight'."}, {'label': '25 <= BMI < 30', 'description': "Body Mass Index (BMI) according to WHO definition. BMI \\>= 25 and \\< 30 is defined as 'overweight'."}, {'label': 'BMI >= 30', 'description': "Body Mass Index (BMI) according to WHO definition. BMI \\>= 30 is defined as 'obese'."}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amstetten', 'country': 'Austria', 'facility': 'General Hospital', 'geoPoint': {'lat': 48.1229, 'lon': 14.87206}}], 'overallOfficials': [{'name': 'Wolfgang Senker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'General Hospital Amstetten'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Wolfgang Senker', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Senior Consultant for orthopedy and orthopedic surgery', 'investigatorFullName': 'Dr. Wolfgang Senker', 'investigatorAffiliation': 'General Hospital Amstetten'}}}}