CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 13 enrolled
Drug / intervention
Point Digitdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04755790
NCT04755790N/ACompleted

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

Point Designs·interventional·Posted Feb 16, 2021·Updated Jan 24, 2024

In Brief

A clinical study evaluating Point Digit for Amputation; Traumatic, Hand. Completed, enrolled 13 participants across 7 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedFeb 16, 2021
Enrollment StartMay 18, 2020
Primary CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.4 years ago

Interventions

Point Digitdevice

Patient is fit with Point Digit partial hand prosthetic system