RecruitingNot ApplicableNCT06501092

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


Sponsor

Point Designs

Enrollment

14 participants

Start Date

Jun 18, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 3 YearsMax Age: 17 Years

Inclusion Criteria4

  • Unilateral or bilateral partial hand limb differences
  • Fluent in English or Spanish
  • Ability to follow simple directions
  • Age between 3 and 17 years

Exclusion Criteria5

  • 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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Interventions

DEVICEPoint Mini

Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets


Locations(2)

Point Designs

Lafayette, Colorado, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

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NCT06501092


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