NCT06501092

To Assess the Utility of the Point Mini in a Clinical Take-home Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (estimated)
• Sponsor: Point Designs · Industry
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or no device. This study will be a single subject crossover design where one group of 14 children with partial hand deficiencies will be evaluated on several metrics using their existing prosthetic treatment for one month and the Point Mini system for two months. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.

Conditions

• Amputation; Traumatic, Hand
• Amputation, Congenital

Interventions

Type	Name	Description
DEVICE	Point Mini	Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets

Timeline

• Start date: 2025-06-18
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2024-07-15
• Last updated: 2025-06-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study