To Validate Point Mini User Needs

NCT ID: NCT06504667

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-29

Study Completion Date

2025-07-29

Brief Summary

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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.

Detailed Description

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Conditions

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Amputation; Traumatic, Hand Amputation, Congenital

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Prosthesis

Patient is temporarily fit with Point Mini finger prosthetic system

Group Type EXPERIMENTAL

Point Mini

Intervention Type DEVICE

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

Interventions

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Point Mini

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Partial hand loss with at least index and/or middle fingers loss at the MCP level
* Intact thumb with full range of motion
* Fluent in English
* Between the ages of 5 and 15 years

Exclusion Criteria

* Patients with a residual limb that is unhealed from the amputation surgery
* Unhealed wounds
* Significant cognitive deficits as determined upon clinical evaluation
* Significant neurological deficits as determined upon clinical evaluation
* Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation
* Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation
* Serious uncontrolled medical problems as judged by the project therapist
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role collaborator

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

NIH

Sponsor Role collaborator

Point Designs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Levin Sliker, PhD

Role: PRINCIPAL_INVESTIGATOR

CEO, Point Designs

Locations

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University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, United States

Site Status

Point Designs

Lafayette, Colorado, United States

Site Status

Countries

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United States

Other Identifiers

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4R44HD113485-02

Identifier Type: NIH

Identifier Source: secondary_id

View Link

445969

Identifier Type: -

Identifier Source: org_study_id