NCT06501092NARecruiting
To Assess the Utility of the Point Mini in a Clinical Take-home Study
Point Designs
Start Date
6/18/2025
Completion Date
7/31/2027
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 no device. This study will be a single subject crossover design where one group of 14 children with partial hand deficiencies will be evaluated on several metrics using their existing prosthetic treatment for one month and the Point Mini system for two months. Metrics include: in-clinic functional measures, subjective assessments, bilateral hand use, and prosthesis wear time.
Eligibility Criteria
Age Range: 3 years to 17 years
Inclusion Criteria:
* Unilateral or bilateral partial hand limb differences
* Fluent in English or Spanish
* Ability to follow simple directions
* Age between 3 and 17 years
Exclusion Criteria:
* Patients with any unhealed wounds on their residual limb(s)
* Significant cognitive deficits as determined upon clinical evaluation
* Inability to follow simple directions
* Significant physical deficits including pain and scarring impacting the design and fitting of the Point Mini prosthesis
* Other psychosocial, personal, and medical co-morbidities expressed by the subject, family or study personnel
Interventions
DEVICE
Point Mini
Conditions
Amputation; Traumatic, HandAmputation, Congenital
Locations
Point Designs
Lafayette, Colorado 80026
United States
Children's Healthcare of Atlanta
Atlanta, Georgia 30143
United States