To Assess the Utility of the Point Mini in a Clinical Take-home Study
Recruiting now · Not applicable
Conditions studied: Amputation; Traumatic, Hand, Amputation, Congenital
In brief
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.
Key facts
- Study ID
- NCT06501092
- Run by
- Point Designs
- People needed
- 14
- Starts
- 2025-06-18
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-06-26
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Unilateral or bilateral partial hand limb differences
- Fluent in English or Spanish
- Ability to follow simple directions
- Age between 3 and 17 years
You may not qualify if…
- 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
Where it is running
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (enrolling)
- Point Designs — Lafayette, Colorado, United States
Full record on ClinicalTrials.gov
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