NCT04755790

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: Point Designs · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will allow us to assess whether the Point Digit confers functional and psychological benefit to persons with partial hand amputations in an unconstrained environment. The use of the Point Digit outside of the laboratory will allow for a wider variety of uses and for a more realistic simulation of the product being used in the field. This well-controlled trial (without randomization of subjects) will produce the first Level II-1 medical evidence in our field of partial hand prosthetic design as described by the 1989 U.S. Preventive Services Task Force. Furthermore, this study will provide important data to support providers who are requesting reimbursement from payers.

Conditions

• Amputation; Traumatic, Hand

Interventions

Type	Name	Description
DEVICE	Point Digit	Patient is fit with Point Digit partial hand prosthetic system

Timeline

• Start date: 2020-05-18
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2021-02-16
• Last updated: 2024-01-24
• Results posted: 2024-01-24

Locations

7 sites across 1 country: United States

Regulatory

• FDA-regulated device study