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NCT06391697 · ClinicalTrials.gov registry record · NA
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
A NA study of Amputation, sponsored by Brigham and Women's Hospital.
- Active
- Registry status
- NA
- Development phase
- 7
- Enrollment target
- 2
- Study locations
NCT06391697 is a NA study of Amputation that is active but no longer recruiting, run by Brigham and Women's Hospital. The registered enrollment target is 7 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (95% lower). The trial reports 2 study locations across 1 state.
The verdict
NCT06391697, a NA study of Amputation, is active but no longer recruiting, sponsored by Brigham and Women's Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 7 participants
- Enrollment target
- 2
- Study locations
Study Summary
The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a bidirectional interface into the human body that allows permanent and reliable communication using implanted electrodes. These electrodes will provide long-term stable bioelectric signals for an improved control of the prosthetic limb. The Magnetic Bead Tracking System, which will be implanted and used in combination with the e-OPRA Implant system, is an investigational device that consists of pairs of magnetic beads, and a set of magnetic field sensors that measure and track the length of muscles and the speed at which they move in real-time. When the beads are implanted in muscle in the residual limb of an amputee, the muscle length signal is communicated to an investigational, robotic ankle-foot prosthesis. The purpose of the study is to evaluate the feasibility of a transtibial amputee with the e-OPRA Implant System and Magnetic Bead Tracking System exhibiting full neural control over a neuro-mechanical prosthetic system. A maximum of seven subjects will be enrolled. Each subject will undergo one or more surgeries where the e-OPRA Implant System and Magnetic Bead Tracking System will be implanted. The subjects will participate in follow-up sessions the last of which occurs approximately 24 months after the surgery. This is a prospective, non-randomized, uncontrolled study.
Conditions Studied
Interventions
- DEVICE eOPRA Implant System for Transtibial Amputees and Magnetic Bead Tracking System
Study Locations (2)
Massachusetts
- Brigham and Women's Hospital - Boston
- MIT Media Lab - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7 participants |
| Start Date | 2024-05-01 |
| Est. Completion | 2027-05-02 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06391697
The ClinicalTrials.gov registry entry for NCT06391697 describes a study currently listed as active not recruiting, categorized as NA. The registered enrollment target is 7 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (95% lower). The listed sponsor is Brigham and Women's Hospital, which has 937 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Amputation appearing as the primary indexed condition, and to 1 intervention - of which eOPRA Implant System for Transtibial Amputees and Magnetic Bead Tracking System is the first listed.
NCT06391697 reports 2 study locations spanning 1 distinct geographic area - top geographies include Massachusetts.
Frequently Asked Questions
What is clinical trial NCT06391697 about?
NCT06391697 is a clinical study titled "Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees". The e-OPRA Implant System, is a further development of the OPRA (Osseointegrated Prostheses for the Rehabilitation of Amputees) Implant System. The e-OPRA Implant system is an implant system for direct skeletal anchorage of amputation prostheses. The added feature in the e-OPRA Implant system, is a ...
What is the current status of trial NCT06391697?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 7 participants. The study started on 2024-05-01. Estimated completion is 2027-05-02.
What conditions does trial NCT06391697 study?
This clinical trial studies the following conditions: Amputation.
What interventions are being tested in trial NCT06391697?
The interventions under investigation include: eOPRA Implant System for Transtibial Amputees and Magnetic Bead Tracking System (DEVICE).
Who is sponsoring clinical trial NCT06391697?
This trial is sponsored by Brigham and Women's Hospital, which has 937 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06391697 being conducted?
This trial has 2 study locations across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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