Ignite Creation Date:
2025-12-24 @ 7:06 PM
Ignite Modification Date:
2025-12-25 @ 4:40 PM
Study NCT ID:
NCT03573557
Status:
COMPLETED
Last Update Posted:
2022-03-23
First Post:
2018-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface
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': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 159}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-22', 'studyFirstSubmitDate': '2018-06-15', 'studyFirstSubmitQcDate': '2018-06-19', 'lastUpdatePostDateStruct': {'date': '2022-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of displacement when in Trendelenburg', 'timeFrame': '1 day', 'description': 'Normal amount of displacement when place in Trendelenburg'}], 'secondaryOutcomes': [{'measure': 'Cost of device', 'timeFrame': '1 day', 'description': 'How cost effective is each surface'}, {'measure': 'Rank of ease of use by physician', 'timeFrame': '1 day', 'description': 'Surgeon will rate how the surface interferes with surgery'}, {'measure': 'Number of adverse events', 'timeFrame': '1 day', 'description': 'Count of adverse events per surface'}, {'measure': 'Erythema score', 'timeFrame': '1 day', 'description': 'Erythema score per surface graded by skin redness'}, {'measure': 'Patient BMI', 'timeFrame': '1 day', 'description': 'Influence of patient BMI on displacement per anti-slip surface'}, {'measure': 'Patient age', 'timeFrame': '1 day', 'description': 'Influence of patient age on displacement per anti-slip surface'}, {'measure': 'Patient weight', 'timeFrame': '1 day', 'description': 'Influence of patient weight on displacement per anti-slip surface'}, {'measure': 'Patient height', 'timeFrame': '1 day', 'description': 'Influence of patient height on displacement per anti-slip surface'}, {'measure': 'Patient Hip circumference', 'timeFrame': '1 day', 'description': 'Influence of patient hip circumference on displacement per anti-slip surface'}, {'measure': 'Patient Waist circumference', 'timeFrame': '1 day', 'description': 'Influence of patient waist circumference on displacement per anti-slip surface'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vaginal Surgery', 'Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': 'To identify the best surface to minimize the risk of intra-operative slipping when placed in Trendelenburg position. The outcomes of interest are to minimize the amount of movement from predefined anatomic landmarks and maximize the ease of performing the intended surgery. The study consists of performing a randomized trial comparing 3 common anti-slip surfaces to determine which surface provides the best result in terms of safety and cost.', 'detailedDescription': 'Laparoscopic surgery has become increasingly important in the drive to reduce patient morbidity. The introduction of robotic surgery has only served to accelerate this trend by allowing more complex surgeries to be performed using a minimally invasive technique. A key requirement of any minimally invasive gynecologic procedure is adequate visualization of the pelvis. This necessitates moving the bowel into the upper abdomen which is facilitated by placing patients in the Trendelenburg position. Steep Trendelenburg in the range of 30-40 degrees has historically been referenced as necessary for adequate visualization, but modern studies have found 16-28 degrees to be adequate. In practice, most physicians obtain the maximum Trendelenburg available as increasingly complex surgeries are attempted using minimally invasive techniques.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients scheduled to undergo major laparoscopic or vaginal surgery by participating physicians at University Hospital Cleveland Medical Center\n* Patients must not be pregnant\n\nExclusion Criteria:\n\n* Pregnancy\n* Patients unable to give consent'}, 'identificationModule': {'nctId': 'NCT03573557', 'briefTitle': 'Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface', 'organization': {'class': 'OTHER', 'fullName': 'Case Comprehensive Cancer Center'}, 'officialTitle': 'Improved Intra-operative Safety From Optimal Selection of Anti-slip Surface', 'orgStudyIdInfo': {'id': 'CASE4817'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Pink Pad', 'description': 'The Pink Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure.', 'interventionNames': ['Device: Pink Pad']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bean Bag', 'description': 'The Bean Bag will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg to determine how much slipping is happening during the procedure.', 'interventionNames': ['Device: Bean Bag']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Gel Pad', 'description': 'The Gel Pad will be used with subjects undergoing laparoscopic surgery or vaginal surgery while in to Trendelenburg determine how much slipping is happening during the procedure.', 'interventionNames': ['Device: Gel Pad']}], 'interventions': [{'name': 'Pink Pad', 'type': 'DEVICE', 'description': 'Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.', 'armGroupLabels': ['Pink Pad']}, {'name': 'Bean Bag', 'type': 'DEVICE', 'description': 'Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.', 'armGroupLabels': ['Bean Bag']}, {'name': 'Gel Pad', 'type': 'DEVICE', 'description': 'Gel Pad used for patients in steep Trendelenburg position during surgery.', 'armGroupLabels': ['Gel Pad']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Sherif El-Nashar, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}