Ignite Creation Date:
2025-12-24 @ 5:30 PM
Ignite Modification Date:
2026-02-22 @ 6:49 PM
Study NCT ID:
NCT02278068
Status:
COMPLETED
Last Update Posted:
2020-03-26
First Post:
2014-10-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-24', 'studyFirstSubmitDate': '2014-10-23', 'studyFirstSubmitQcDate': '2014-10-28', 'lastUpdatePostDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety Outcome as assessed by Incidence of serious adverse device effects', 'timeFrame': '180 day follow-up', 'description': 'Incidence of serious adverse device effects'}], 'secondaryOutcomes': [{'measure': 'Device and Procedural success', 'timeFrame': 'intra operative', 'description': 'Incidence of successful energy delivery, incidence of serious adverse device effects with 24 hours of procedure'}, {'measure': 'Glycemic control', 'timeFrame': '180 day and 365 day follow-up', 'description': 'Number of subjects with a decrease in HbA1c, change in plasma glucose based on fasting glucose and oral glucose tolerance test'}, {'measure': 'Laboratory Assessments/Cardiometabolic Changes', 'timeFrame': '180 day follow up', 'description': 'Assessment of chemistry/serum lab values to evaluate safety and performance'}, {'measure': 'Adverse Event Rate', 'timeFrame': '365 day follow up', 'description': 'Summary of all reported adverse events during the study'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Type 2 diabetes'], 'conditions': ['Diabetes', 'Endocrine, Nutritional and Metabolic Diseases (E00-E89)']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to collect information about a new treatment for Type 2 Diabetes Mellitus (T2DM), using a medical device called the Metabolic Neuromodulation System which is intended to help regulate blood glucose levels in patients whose (T2DM) is not well controlled despite treatment with multiple medications. The medical device delivers low-level radiofrequency energy through the wall of the blood vessel to the liver to disrupt the nerves that lead to the liver. Previous research has shown that disrupting these nerves may lead to a lowering of blood sugar levels.', 'detailedDescription': 'Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-65 years\n* Uncontrolled T2DM, as evidenced by HbA1c levels, on a consistent oral anti-hyperglycemic drug regimen of at least two different drug classes\n* Documented status of stable lifestyle modifications\n\nExclusion Criteria:\n\n* Diagnosed type 1 diabetes mellitus\n* History or diagnosis of proliferative retinopathy or advanced autonomic neuropathy\n* Estimated glomerular filtration rate (GFR) \\< 60mL/min/1.73m2'}, 'identificationModule': {'nctId': 'NCT02278068', 'briefTitle': 'COMPLEMENT Study- A First in Human Study of Metabolic Neuromodulation Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Metavention'}, 'officialTitle': 'A First in Human (FIH) Clinical Study to Assess Safety and Performance of Hepatic Sympathetic Denervation for Treatment of Inadequately Controlled Type 2 Diabetic Subjects on Oral Antihyperglycemic Agents.', 'orgStudyIdInfo': {'id': 'MV-2014-ANZ-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metabolic Neuromodulation System (MNS)', 'description': 'Hepatic sympathetic denervation therapy to aid in glycemic control', 'interventionNames': ['Device: Metabolic Neuromodulation System (MNS)']}], 'interventions': [{'name': 'Metabolic Neuromodulation System (MNS)', 'type': 'DEVICE', 'otherNames': ['Hepatic sympathetic denervation'], 'description': 'Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control.', 'armGroupLabels': ['Metabolic Neuromodulation System (MNS)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Auckland City Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'Middlemore Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Auckland', 'country': 'New Zealand', 'facility': 'North Shore Hospital', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}, {'city': 'Christchurch', 'country': 'New Zealand', 'facility': 'Christchurch Hospital', 'geoPoint': {'lat': -43.53333, 'lon': 172.63333}}, {'city': 'Dunedin', 'country': 'New Zealand', 'facility': 'Dunedin Hospital', 'geoPoint': {'lat': -45.87416, 'lon': 170.50361}}, {'city': 'Wellington', 'country': 'New Zealand', 'facility': 'Wellington Hospital', 'geoPoint': {'lat': -41.28664, 'lon': 174.77557}}], 'overallOfficials': [{'name': 'Mark Webster, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Auckland City Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Metavention', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}