NCT07135947

To Evaluate the Clinical Impact of the Point Powered System

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Point Designs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment. This study will be a single subject crossover design where one group of 10 adult partial hand amputees will be evaluated on several metrics on their existing prosthetic treatment (Treatment 1) and the Point Powered system (Treatment 2) over a period of three months using standard two-site myoelectric control. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.

Conditions

• Amputation; Traumatic, Hand

Interventions

Type	Name	Description
DEVICE	Point Powered partial hand prosthetic system	The Point Powered system includes 1-4 3-joint mechatronic digits, low-profile EMG electrodes, a low-profile controller, and flexible batteries. These components will be integrated into a waterproof and dustproof packaging

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-03-01
• Completion: 2026-08-31
• First posted: 2025-08-22
• Last updated: 2025-08-22

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study