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

NCT03644394 | Completed DMC FDA Device

• 1 other identifier: 1320/2014
• Study Type: interventional
• Target: 3
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Amputation

Outcome Measures

Primary Outcomes (1)

• Change in hand function over time

  Southampton Hand Assessment Procedure

  at 3, 6, 9 and 12 months after final prosthetic fitting

Study Arms (1)

Implantation

OTHER

Surgical Implantation of IMES sensors

Device: Implantation of IMES sensors

Interventions

Implantation of IMES sensors DEVICE

Surgical implantation of IMES sensors during routine surgery to improve prosthetic control

Implantation

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Officials

• Christian Hofer, PhD

  Otto Bock

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Subinvestigator

Study Record Dates

• First Submitted: August 11, 2018
• First Posted: August 23, 2018
• Study Start: August 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will not share