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

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary and study completion dates: Jul 31, 2026 to Jul 31, 2027
    • Primary endpoints: 8 to 2
    • Eligibility criteria shortened, about 30 words
    v7
  2. Minor Primary and study completion dates: Aug 31, 2026 to Jul 31, 2026
    • Start date changed from estimate of Jun 30, 2025 to Jun 18, 2025
    v6
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 3, 2025 to Jun 30, 2025
    • Site details revised at 2 of 2 sites
    v5
  4. Notable Start date: Feb 1, 2025 to Mar 3, 2025
    • Site contacts updated at 2 of 2 sites
    • Collaborators: 1 to 2
    v4
  5. Notable Start date: Nov 1, 2024 to Feb 1, 2025v3
  6. Notable Primary and study completion dates: Nov 1, 2025 to Aug 31, 2026v2
  7. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06501092
Lead Sponsor Point Designs
Collaborators: Children's Healthcare of Atlanta, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions
(from sponsor)
Amputation; Traumatic, Hand, Amputation, Congenital
Related terms Amputation, Congenital
Enrollment 14 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov