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NCT04043234 · ClinicalTrials.gov registry record
RESCU System for Robust Upper Limb Prosthesis Control
A clinical trial of Amputation and Upper Limb, sponsored by Infinite Biomedical Technologies.
- Completed
- Registry status
- 4
- Enrollment target
- 1
- Study location
NCT04043234 is a study of Amputation and Upper Limb that has completed, run by Infinite Biomedical Technologies. The registered enrollment target is 4 participants, below the 133-participant average among 65 other Amputation trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04043234, a study of Amputation and Upper Limb, has completed, sponsored by Infinite Biomedical Technologies.
- COMPLETED
- Registry status
- 4 participants
- Enrollment target
- 1
- Study location
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 |
Interested in This Trial?
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, categorized as an unspecified phase. The registered enrollment target is 4 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 (97% lower). The listed sponsor is Infinite Biomedical Technologies, which has 4 total studies on file at ClinicalTrials.gov.
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.
NCT04043234 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
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.
What interventions are being tested in trial NCT04043234?
The interventions under investigation include: RESCU (DEVICE), Pattern Recognition (DEVICE).
Who is sponsoring clinical trial NCT04043234?
This trial is sponsored by Infinite Biomedical Technologies, which has 4 total clinical trials registered on ClinicalTrials.gov.
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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Related
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