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NCT06501092 · ClinicalTrials.gov registry record · NA
To Assess the Utility of the Point Mini in a Clinical Take-home Study
A NA study of Amputation; Traumatic, Hand and Amputation, Congenital, sponsored by Point Designs.
- Recruiting
- Registry status
- NA
- Development phase
- 14
- Enrollment target
- 2
- Study locations
NCT06501092: Recruiting NA study of Amputation; Traumatic, Hand and Amputation, Congenital, sponsored by Point Designs.
NCT06501092 is a NA study of Amputation; Traumatic, Hand and Amputation, Congenital that is actively recruiting participants, run by Point Designs. The registered enrollment target is 14 participants, below the 20-participant average among 4 other Amputation; Traumatic, Hand trials with a reported enrollment target (30% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06501092, a NA study of Amputation; Traumatic, Hand and Amputation, Congenital, is actively recruiting participants, sponsored by Point Designs.
- RECRUITING
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
The PUFI-2 is a measure of manual ability for children with upper limb impairment with and without a prosthesis. PUFI-2 consists of a questionnaire listing 23-27 manual activities and asks how the child performs the activity, how difficult it is to complete, and whether the prosthesis is useful or not. Both self-report and parent proxy-report versions are available.
Conditions Studied
Interventions
- DEVICE Point Mini
Study Locations (2)
Colorado
- Point Designs - Lafayette
Georgia
- Children's Healthcare of Atlanta - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2025-06-18 |
| Est. Completion | 2026-07-31 |
| Phase | NA |
What NCT06501092 shows while recruiting
NCT06501092 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 participants, a relatively small participant target, below the 20-participant average among 4 other Amputation; Traumatic, Hand trials with a reported enrollment target (30% lower).
The record links to 2 conditions, with Amputation; Traumatic, Hand appearing as the primary indexed condition, and to 1 intervention - of which Point Mini is the first listed.
NCT06501092 reports a single indexed study location in Colorado, Georgia.
Frequently Asked Questions
What is clinical trial NCT06501092 about?
NCT06501092 is a clinical study titled "To Assess the Utility of the Point Mini in a Clinical Take-home Study". 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 ...
What is the current status of trial NCT06501092?
This trial is currently recruiting. It is a NA study. The enrollment target is 14 participants. The study started on 2025-06-18. Estimated completion is 2026-07-31.
What conditions does trial NCT06501092 study?
This clinical trial studies the following conditions: Amputation; Traumatic, Hand, Amputation, Congenital.
What interventions are being tested in trial NCT06501092?
The interventions under investigation include: Point Mini (DEVICE).
Who is sponsoring clinical trial NCT06501092?
This trial is sponsored by Point Designs, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06501092 being conducted?
This trial has 2 study locations across Colorado, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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