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Validation of User Needs of the Point Digit With Partial Hand Amputees

NCT04763278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2024-09-27

Study results available
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Summary

The objective of the device feasibility study will be to validate the user needs of the Point Digit system. This study will be a single group intervention model where one group of 5 partial hand amputees will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.

Conditions

  • Amputation; Traumatic, Hand

Interventions

DEVICE

Point Digit

The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket

Sponsors & Collaborators

  • University of Colorado, Denver

    collaborator OTHER

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    collaborator NIH

  • Point Designs

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-07
Primary Completion
2022-03-30
Completion
2022-03-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04763278 on ClinicalTrials.gov