Status:
RECRUITING
To Assess the Utility of the Point Mini in a Clinical Take-home Study
Lead Sponsor:
Point Designs
Collaborating Sponsors:
Children's Healthcare of Atlanta
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 this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, which may include a prosthesis, other assistive device, or ...
Eligibility Criteria
Inclusion
- Partial hand loss with at least index and/or middle finger loss at the metacarpophalangeal (MCP) level
- Intact thumb with full range of motion
- Fluent in English
- Age between 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 :
June 18 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2026
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT06501092
Start Date
June 18 2025
End Date
July 31 2026
Last Update
June 24 2025
Active Locations (2)
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1
Point Designs
Lafayette, Colorado, United States, 80026
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30143