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: 5 YearsMax Age: 15 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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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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