Implantable MyoElectric Sensors (IMES) for Prosthetic Con... | NCT03644394

Studies
Implantable MyoElectric Sensors (IMES) for Prosthetic Control in Transhumeral Amputees

NCT03644394

Sponsor

Medical University of Vienna

Status

Completed

Last Update Posted

Aug 23, 2018Actual

Enrollment

3Actual

Phase

Not Applicable

Conditions

Amputation

Interventions

Implantation of IMES sensors

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014Actual

Primary Completion Date

Oct 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Aug 11, 2018

First Submission Date that Met QC Criteria

Aug 21, 2018

First Posted Date

Aug 23, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 21, 2018

Last Update Posted Date

Aug 23, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Stefan Salminger, Subinvestigator, Medical University of ViennaPrincipal Investigator

Lead Sponsor

Medical University of ViennaOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

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).

Each 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.

An 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

3Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Implantation	Other	Surgical Implantation of IMES sensors	Device: Implantation of IMES sensors

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implantation of IMES sensors	Device	Surgical implantation of IMES sensors during routine surgery to improve prosthetic control	Implantation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in hand function over time	Southampton Hand Assessment Procedure	at 3, 6, 9 and 12 months after final prosthetic fitting

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unilateral transhumeral amputation
can speak and comprehend German
undergone amputee rehabilitation, including being trained to wear and use a conventional myoelectric prosthesis
residual upper limb meets the criterions for TMR surgery

Exclusion Criteria:

Known genetic neuromuscular disorder
bleeding or clotting disorder
active implant
any metal fragments or metal implants located within the residual upper limb stump
Female patients if pregnant or breast-feeding

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

16 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christian Hofer, PhD	Otto Bock	Study Chair

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

The study including all results is already submitted to be published

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided