To Validate Point Mini User Needs

NCT06504667 | Withdrawn FDA Device

• 2 other identifiers: 4459694R44HD113485-02
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (10)

• VAL-1

  User wears Point Mini(s) for a entire session without discomfort (Pass/Fail)

  Day 1 (8 hours)

• VAL-2

  User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail)

  Day 1 (10 minutes)

• VAL-3.1

  User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail)

  Day 1 (10 minutes)

• VAL-3.2

  User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail)

  Day 1 (10 minutes)

• VAL-4

  User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail)

  Day 1 (10 minutes)

• VAL-5

  User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail)

  Day 1 (10 minutes)

• VAL-6

  User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail)

  Day 1 (10 minutes)

• VAL-7

  User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail)

  Day 1 (10 minutes)

• VAL-8

  User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail)

  Day 1 (10 minutes)

• VAL-9

  User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail)

  Day 1 (8 hours)

Study Arms (1)

Prosthesis

EXPERIMENTAL

Patient is temporarily fit with Point Mini finger prosthetic system

Device: Point Mini

Interventions

Point Mini DEVICE

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

Prosthesis

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Point Designs: lead
• University of Colorado, Denver: collaborator
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (2)

University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Point Designs

Lafayette, Colorado, 80026, United States

Location

MeSH Terms

Conditions

Amputation, Congenital

Study Officials

• Levin Sliker, PhD

  CEO, Point Designs

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 17, 2024
• Study Start: July 29, 2025
• Primary Completion: July 29, 2025
• Study Completion: July 29, 2025
• Last Updated: December 17, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)