Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When U… (NCT07195461) | Clinical Trial Compass
RecruitingEarly Phase 1
Feasibility Study Evaluating the Safety and Effectiveness of Magnetic Bead Tracking System When Used With a Bionic External Prosthesis
United States3 participantsStarted 2025-09-11
Plain-language summary
The investigation is an early feasibility study in up to 5 subjects, in which the primary objective is to capture preliminary safety and effectiveness information on the Magnetic Bead Tracking system.
Who can participate
Age range22 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or Female age 22-65 at the time of surgery.
* The patient must already have an existing unilateral or bilateral transtibial amputation requiring revision or a medical condition requiring performance of a unilateral or bilateral transtibial amputation.
* If the patient does not already have an amputation, the patient must have undergone independent consultation with a lower extremity surgical specialist to ensure they have exhausted all limb salvage options prior to undergoing amputation, as well as a psychiatric evaluation to ensure appropriate capacity and volition, and a pain medicine evaluation to ensure that all pain control options outside of amputation have been addressed.
* The patient must have the ability to ambulate at variable cadence (an expected lower extremity prosthesis functional level of K3 or above, as determined by a trained and certified prosthetist and confirmed by study investigators, through use of a patient history and physical examination).
* The patient must have adequate soft tissue bulk and muscle mass present in the operative limb to support appropriate wound healing.
* The patient must demonstrate volitional activation of the muscles into which magnet placement is intended.
* In the opinion of the investigator, the patient must likely be able to tolerate the pressure of a prosthetic socket during ambulation post-operatively.
* In the opinion of the investigator, the patient must have absence of any physical limitations…