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To Assess the Utility of the Point Mini in a Clinical Take-home Study

RecruitingNAAges 3 Years - 17 YearsAllPoint Designs
NCT06501092 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Point Mini
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Where

2 sites
Point Designs
Lafayette, United States
Children's Healthcare of Atlanta
Atlanta, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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