Ignite Creation Date:
2025-12-24 @ 6:58 PM
Ignite Modification Date:
2025-12-29 @ 4:16 AM
Study NCT ID:
NCT04391257
Status:
COMPLETED
Last Update Posted:
2022-08-05
First Post:
2020-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of gekoTM Interaction With Cardiac Pacemakers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-11-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-04', 'studyFirstSubmitDate': '2020-04-30', 'studyFirstSubmitQcDate': '2020-05-12', 'lastUpdatePostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary endpoint is percentage of pacemaker sensed geko™ pulses in a 30 second period.', 'timeFrame': 'One day - single follow-up.', 'description': 'Interference with pacemaker function.'}], 'secondaryOutcomes': [{'measure': 'The secondary endpoints are the incidence of adverse events (AEs), incidence of serious AEs (SAEs), incidence of study treatment related AEs, and the incidence of investigational device related AEs.', 'timeFrame': 'One day-single follow-up.', 'description': 'Incidence of adverse and serious adverse events.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stroke', 'Wound Heal', 'Edema Leg', 'Cardiac Pacemaker Electrical Interference']}, 'descriptionModule': {'briefSummary': 'The gekoTM device is a small disposable battery powered device that attaches to the lower leg near the knee and stimulates the common peroneal nerve, causing muscle contraction of the lower leg. This contraction increases blood flow and the device is used to treat several conditions including deep vein thrombosis and venous leg ulcers.\n\nThere is evidence that some powered muscle stimulators and related devices can affect Cardiac Demand Pacemakers. This study is to ascertain if there is any such interaction between the gekoTM device and permanently implanted cardiac pacemakers.', 'detailedDescription': "CFR.890.5850 requires that the labelling for powered muscle stimulators includes the contraindication 'Powered muscle stimulators should not be used on patients with cardiac demand pacemakers'.\n\nFurther, IEC 60601-2-10:2012 clause 210.7.9.2.101d, requires that the instructions for use provide: 'Advice that a PATIENT with an implanted electronic device (for example a cardiac pacemaker) should not be subjected to stimulation unless specialist medical opinion has first been obtained'. However, no details on what criteria the specialist should apply.\n\nThere is evidence that some powered muscle stimulators, and related devices can affect Cardiac Demand Pacemakers(1,2). Traditional powered muscle stimulators use pulse trains at a frequency of at least 30Hz(3) to elicit muscle contractions. The electrodes for these devices may be placed at number of sites on the body depending on the application, including the legs, arms and torso, often with well-spaced electrodes that may be attached to different limbs, sending electrical impulses through the torso.\n\nThe geko™ range of devices, however operate by delivering a single pulse at a frequency of 1Hz with electrodes placed topically, close together, at the knee. The nature of the stimulation pulse, and its location make it extremely unlikely that the geko™ devices could interfere with cardiac demand pacemakers. However, there is no direct evidence to support this assumption. This trial will determine if there are any adverse interactions between the geko™ and cardiac pacemakers."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged ≥ 18 years and able to provide written informed consent.\n* Intact healthy skin at the site of geko™ device application.\n* Patient has a single, dual or bi-ventricular pacemaker implanted and is not pacing dependent.\n* Patient understands and is willing to participate in the study and is able to comply with study procedures and visits.\n\nExclusion Criteria:\n\n* Pregnancy or breast feeding.\n* Use of any concurrent use of a neuro-modulation device.\n* Any medication deemed by the Investigator to potentially interfere with the study treatment (e.g. systemic steroids.)\n* Participation in any other clinical study that may interfere with the outcome of either study'}, 'identificationModule': {'nctId': 'NCT04391257', 'briefTitle': 'Study of gekoTM Interaction With Cardiac Pacemakers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Firstkind Ltd'}, 'officialTitle': 'A Prospective Trial to Determine if it is Safe to Use the gekoTM Neuromuscular Electrostimulation Device in a Pacemaker Population.', 'orgStudyIdInfo': {'id': 'FSK-CVD-003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Main', 'description': 'gekoTM neuromuscular electrostimulation device (NMES) briefly used on patients with cardiac pacemakers to check if pacemakers detect the gekoTM electrical pulses as interference.', 'interventionNames': ['Device: geko™']}], 'interventions': [{'name': 'geko™', 'type': 'DEVICE', 'description': 'Assess if cardiac pacemakers detect geko™ electrical output pulse.', 'armGroupLabels': ['Main']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'CF14 4XW', 'city': 'Cardiff', 'country': 'United Kingdom', 'facility': 'University Hospital of Wales', 'geoPoint': {'lat': 51.48, 'lon': -3.18}}, {'zip': 'DY1 2HQ', 'city': 'Dudley', 'country': 'United Kingdom', 'facility': 'The Dudley Group NHS Foundation Trust', 'geoPoint': {'lat': 52.5, 'lon': -2.08333}}], 'overallOfficials': [{'name': 'Zaheer Yousef, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital of Wales, Cardiff'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Firstkind Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}