Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-01-15 @ 4:25 AM
Study NCT ID:
NCT03644394
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2018-08-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-21', 'studyFirstSubmitDate': '2018-08-11', 'studyFirstSubmitQcDate': '2018-08-21', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hand function over time', 'timeFrame': 'at 3, 6, 9 and 12 months after final prosthetic fitting', 'description': 'Southampton Hand Assessment Procedure'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Amputation']}, 'descriptionModule': {'briefSummary': 'The Implantable Myoelectric Sensors (IMES) system is an investigational device intended to improve signal quality and consistency of myoelectric signals for prosthetic control in individuals suffering from an above elbow (transhumeral) amputation. The sensors pick up myoelectric signals intramuscularly and therefore signal quality is not affected from electrode replacement, perspiration, or artefacts.', 'detailedDescription': 'Implantable Myoelectric Sensors (IMES), the surgical tools implantation, and the external equipment used to control an electromechanical prosthetic device, together comprise the IMES System (investigational product, medical device).\n\nEach IMES acts as an independent differential amplifier consisting of custom electronics housed within a biocompatible, hermetically sealed ceramic cylinder with metal end caps. The end caps serve as electrodes for picking up EMG activity during muscle contraction. Reverse telemetry (via a coil around the arm) is used to transfer data from the implanted sensor, and forward telemetry is used to transmit power and configuration settings to the sensors. The coil and associated electronics are housed within the frame of a prosthesis. A control system that sends data associated with muscle contraction to the motors of the prosthetic joints is housed in a belt-worn, battery-powered device. A cable attaches the control unit to the prosthetic frame.\n\nAn IMES is implanted into each targeted muscle that will be used to control a function of the prosthetic arm. Two IMES devices are needed for each DOF. For example, one device would control fingers opening and another device would control fingers closing.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* unilateral transhumeral amputation\n* can speak and comprehend German\n* undergone amputee rehabilitation, including being trained to wear and use a conventional myoelectric prosthesis\n* residual upper limb meets the criterions for TMR surgery\n\nExclusion Criteria:\n\n* Known genetic neuromuscular disorder\n* bleeding or clotting disorder\n* active implant\n* any metal fragments or metal implants located within the residual upper limb stump\n* Female patients if pregnant or breast-feeding'}, 'identificationModule': {'nctId': 'NCT03644394', 'acronym': 'TH-IMES', 'briefTitle': 'Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees', 'orgStudyIdInfo': {'id': '1320/2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Implantation', 'description': 'Surgical Implantation of IMES sensors', 'interventionNames': ['Device: Implantation of IMES sensors']}], 'interventions': [{'name': 'Implantation of IMES sensors', 'type': 'DEVICE', 'description': 'Surgical implantation of IMES sensors during routine surgery to improve prosthetic control', 'armGroupLabels': ['Implantation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Christian Hofer, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Otto Bock'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The study including all results is already submitted to be published'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Subinvestigator', 'investigatorFullName': 'Stefan Salminger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}