Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-04-24 @ 2:51 AM
Study NCT ID:
NCT01929902
Status:
COMPLETED
Last Update Posted:
2022-04-27
First Post:
2013-08-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-04', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2013-08-23', 'studyFirstSubmitQcDate': '2013-08-27', 'lastUpdatePostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy of the Aquamantys Device', 'timeFrame': '1 year', 'description': 'Efficacy of device will be measured based on intra-operative and post-operative complication variables: estimated blood loss, blood transfusion, complications intra-operative and post-operative.'}, {'measure': 'Placement of Aquamantys Device', 'timeFrame': '1 year', 'description': 'Evaluation of device placement will be measured based on vessel sealing variables: number of applications, vessel site, type of tissue to be sealed, number of failed and successful seals, tissue sticking, tissue color, thermal spread and desiccation.'}], 'secondaryOutcomes': [{'measure': 'Device Complications', 'timeFrame': '1 year', 'description': 'Functional evaluation of device based on the variable: device malfunction.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancer, Hepatocellular', 'Pancreatectomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test the efficacy and accuracy of the Aquamantys device.', 'detailedDescription': 'The primary objective of this study is to assess the efficacy of placement and accuracy of the Aquamantys device in 20 patients that require general surgery. High frequency electrosurgery is the application of frequency in the range of 300 kHz up to several MHz in order to coagulate or destroy tissue. Due to technological advancements, knowledge of how frequency and other physical modes interact with biological materials has become increasingly important in order for the surgeon to provide a safe and consistent surgery. The Aquamantys system utilizes radiofrequency energy and saline irrigation for cutting tissue and stopping excessive bleeding.\n\nThe Aquamantys system features the following:\n\n1. Cone-shaped electrodes designed to aid blunt dissection;\n2. Large bipolar electrode configuration allowing for hemostatic sealing across broad planes of tissue;\n3. Bipolar electrodes alleviate the need for grounding pad;\n4. Transcollation technology allows for controlled depth of energy penetration.\n\nDuring surgery, the Aquamantys device will be utilized in order to stop excessive bleeding and to cut vessels. The patient will be monitored by the surgeon and research nurse coordinator before surgery, intra-operatively and post-operatively until discharge from the hospital. The study participant will follow-up post-operatively with the surgeon per standard of care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female patients age 18 years or older and in need of general surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Indication for general surgery to include: liver resection and pancreatectomy\n* Male or females age 18 years of age or older\n\nExclusion Criteria:\n\n* Indication for emergency surgery\n* Suspected inability, e.g. language problems or the inability to comply with trial procedures\n* Employee at the investigational center, Sponsor or Sponsor's representative, relative or spouse of the investigator\n* Females who are pregnant or breastfeeding"}, 'identificationModule': {'nctId': 'NCT01929902', 'briefTitle': 'Evaluation of Efficacy and Accuracy of Aquamantys Device in General Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Wake Forest University Health Sciences'}, 'officialTitle': 'Laparoscopic Aquamantys Device in General Surgery: A Prospective Observational Study to Evaluate the Efficacy and Accuracy', 'orgStudyIdInfo': {'id': '07-13-04E'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Surgical Patients'}]}, 'contactsLocationsModule': {'locations': [{'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolinas Healthcare System', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}], 'overallOfficials': [{'name': 'David Iannitti, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wake Forest University Health Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wake Forest University Health Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medtronic', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}