e-OPRA Implant System for Transtibial Amputees for Amputation

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Amputatione-OPRA Implant System for Transtibial Amputees - Device
Eligibility
22 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at a new implant system that allows for communication between the body and a prosthetic limb using implanted electrodes. The study is to evaluate the feasibility of the system and will implant the system in two subjects.

Treatment Effectiveness

Study Objectives

3 Primary · 1 Secondary · Reporting Duration: 24 months

24 months
Electrode Robustness and Connector/Lead Integrity (amplitude)
Electrode Robustness and Connector/Lead Integrity (resistance)
Preferred Walking Speed
Sensor Function and Signal Quality

Trial Safety

Trial Design

1 Treatment Group

e-OPRA Implant System for Transtibial Amputees
1 of 1

Experimental Treatment

2 Total Participants · 1 Treatment Group

Primary Treatment: e-OPRA Implant System for Transtibial Amputees · No Placebo Group · N/A

e-OPRA Implant System for Transtibial Amputees
Device
Experimental Group · 1 Intervention: e-OPRA Implant System for Transtibial Amputees · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 months

Who is running the clinical trial?

IntegrumIndustry Sponsor
5 Previous Clinical Trials
166 Total Patients Enrolled
Brigham and Women's HospitalOTHER
1,480 Previous Clinical Trials
9,735,823 Total Patients Enrolled
Massachusetts Institute of TechnologyLead Sponsor
87 Previous Clinical Trials
18,351,308 Total Patients Enrolled

Eligibility Criteria

Age 22 - 65 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a male or female aged 22-65 years at the time of surgery.
You are able to ambulate at variable cadence.
The patient must have adequate bone stock to support the implanted device.
The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing and muscle end organ construction.

Who else is applying?

What state do they live in?
Nevada33.3%
Massachusetts33.3%
Michigan33.3%
How old are they?
18 - 65100.0%
What site did they apply to?
Brigham and Women's Hospital33.3%
MIT Media Lab66.7%
What portion of applicants met pre-screening criteria?
Met criteria100.0%

How responsive is this trial?

Most responsive sites:
  1. MIT Media Lab: < 48 hours
Average response time
  • < 2 Days
Typically responds via
Email100.0%