Publication date context: February 19, 2026. A study coordinated by the University of Pisa is evaluating a multimodal tactile feedback system for users with upper limb loss. The trial aims to measure embodiment and performance in amputees. The device tests include pressure and vibrotactile feedback, alone and in combination. The study is currently recruiting according to ClinicalTrials.gov, reference NCT07418645.
What device and trial entail?
The device under study is a multimodal tactile feedback system for upper limb loss. The interventions listed include pressure and vibrotactile feedback, device for pressure feedback and device for vibrotactile feedback, and combinations of these modalities. The study population is amputees and the sponsor is the University of Pisa. The trial is currently recruiting, per ClinicalTrials.gov entry NCT07418645.
What evidence will be collected on embodiment and performance?
Investigators plan to assess embodiment when users interact with the tactile feedback system. The study will also evaluate performance on tasks that use haptic cues. Endpoints will be defined in the study protocol and focus on subjective experiences and objective measures. The information here reflects the conditions listed in the trial entry and sponsor details. Readers should monitor the trial record for results and updates.
Who sponsors the study and what is the recruitment status?
The project is sponsored by the University of Pisa. Recruitment is listed as ongoing in the trial registry. The entry notes the interventions involving pressure and vibrotactile feedback in amputees.
What are the regulatory implications for stakeholders?
Findings from this evaluation may influence how tactile feedback devices for upper limb prosthetics are designed and assessed for safety and performance. Observers will consider benefits in embodiment against safety signals typically reviewed during device evaluation under regulatory frameworks. The language mirrors the expectations of MDR Annex XIV for intended use and performance signals while clarifying that the statements come from the study sponsor.
What should readers monitor next?
Readers should watch for updates on ClinicalTrials.gov and from the sponsor as the study progresses. Results and status changes will be posted as available. The trial identifier is NCT07418645 and the registry record provides ongoing information.
- 1. What is the study about?
The study evaluates a multimodal tactile feedback system for amputees focusing on embodiment and performance.
- 2. Who funds the study and where?
The sponsor is the University of Pisa and the trial is listed on ClinicalTrials.gov.
- 3. What devices are tested?
Feedback modalities include pressure feedback and vibrotactile feedback, tested alone and in combination.
- 4. How can I learn more?
See the ClinicalTrials.gov entry NCT07418645 for details and recruitment status.
Conclusion and implications for practitioners
The study represents a focused effort to evaluate user centered outcomes for tactile feedback in upper limb prosthetics. Depending on results, the work could inform future device development, clinical testing and regulatory planning. Stakeholders should track the trial registry for updates and consider how embodiment and performance data align with safety and performance expectations.
Disclaimer for professionals This article is for professional use and is not legal advice or healthcare guidance. Consult regulatory counsel for compliance questions.
https://clinicaltrials.gov/study/NCT07418645?term=medical+device