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

Part of paid clinical trials in Lafayette, Colorado.

Sponsor
Point Designs
Study ID
NCT06501092
Status
Recruiting
Apply to this trial

Conditions

  • Amputation, Congenital
  • Amputation; Traumatic, Hand

Eligibility Criteria

Sex
ALL
Age
5 Years - 15 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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 Dates

Start date
Jun 18, 2025
Status verified
Jun 2025
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
14 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • No Intervention: Current/No Device
    Baseline outcome measurements will be performed with subject's existing partial hand prosthetic treatment, as deemed standard-of-care by the patient's prosthetist. Device types include, but are not limited to, no prosthesis, passive prosthesis, passive positional prosthesis, body-powered prosthesis, myoelectric prosthesis, or other assistive device.
  • Experimental: Point Mini
    Outcome measurements will be performed after the subject has been fit with a prosthesis at 3 different points in time: immediately post-fitting, \~30 days post-fitting, and \~60 days post-fitting.

Primary Outcome Measure

ABILHAND-Kids [ Time Frame: Baseline (pre-fitting) ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Point DesignsLafayetteColorado80026
Rebecca Connolly
[email protected]
720-600-4753
Levin Sliker, PhD
[email protected]
720-600-4753
Children's Healthcare of AtlantaAtlantaGeorgia30143
Colleen Coulter
[email protected]
404-785-5684
Rebecca Connolly
[email protected]
720-600-4753

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