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RESCU System for Robust Upper Limb Prosthesis Control
NCT04043234 · View on ClinicalTrials.gov ↗
Study Summary
This study will compare the use of RESCU \[Experimental\] Prosthesis with a \[Standard\] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient population. Each of the participants will use the Standard and Experimental and systems over a 35-day period. The Standard system will include at least two controllable DoFs (hand, wrist, multi-articulated hand, etc) and a commercially-available pattern recognition controller. The RESCU system will use the same components as the Standard system but will differ with respect to incorporating eight IBT Element Electrodes (as required for pattern recognition control) and the RESCU control software. The hypothesis is that pattern recognition will outperform the commercially-available control strategy for most participants on in-clinic, at-home usage, and subjective measures.
Conditions Studied
Interventions
- DEVICE RESCU
- DEVICE Pattern Recognition
Study Locations (1)
Maryland
- Medical Center O&P — Silver Spring
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2023-11-07 |
| Est. Completion | 2023-12-19 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04043234
The ClinicalTrials.gov registry entry for NCT04043234 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 4 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Infinite Biomedical Technologies, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Amputation appearing as the primary indexed condition, and to 2 interventions — of which RESCU is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04043234 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04043234 about?
NCT04043234 is a clinical study titled "RESCU System for Robust Upper Limb Prosthesis Control". This study will compare the use of RESCU \[Experimental\] Prosthesis with a \[Standard\] pattern recognition prosthesis in a clinical setting and in unsupervised daily activity. The protocol will follow a single case experimental design (SCED) to compensate for the limited size of the patient popula...
What is the current status of trial NCT04043234?
This trial is currently completed. The enrollment target is 4 participants. The study started on 2023-11-07. Estimated completion is 2023-12-19.
What conditions does trial NCT04043234 study?
This clinical trial studies the following conditions: Amputation, Upper Limb. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04043234?
The interventions under investigation include: RESCU (DEVICE), Pattern Recognition (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04043234?
This trial is sponsored by Infinite Biomedical Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04043234 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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