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To Validate Point Mini User Needs

NCT06504667 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2025-12-17

No results posted yet for this study

Summary

The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss 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
  • Amputation, Congenital

Interventions

DEVICE

Point Mini

The Point Mini finger prosthetic system consists of 1-4 ratcheting mechanical digits and mounting brackets

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

Principal Investigators

  • Levin Sliker, PhD · CEO, Point Designs

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-29
Primary Completion
2025-07-29
Completion
2025-07-29
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 NCT06504667 on ClinicalTrials.gov