Status:
WITHDRAWN
To Validate Point Mini User Needs
Lead Sponsor:
Point Designs
Collaborating Sponsors:
University of Colorado, Denver
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Amputation; Traumatic, Hand
Amputation, Congenital
Eligibility:
All Genders
5-15 years
Phase:
NA
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 parti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 29 2025
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 29 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT06504667
Start Date
July 29 2025
End Date
July 29 2025
Last Update
December 17 2025
Active Locations (2)
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1
University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, United States, 80045
2
Point Designs
Lafayette, Colorado, United States, 80026