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Prosthetic Device

Point Mini for Congenital Amputation

N/A
Waitlist Available
Research Sponsored by Point Designs
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Partial hand loss with at least index and/or middle finger loss at the metacarpophalangeal (MCP) level
* Intact thumb with full range of motion
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 3 months
Awards & highlights

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.

Who is the study for?
This trial is for children with partial hand deficiencies due to congenital or traumatic amputation. Participants will be compared using their current prosthetic treatment, if any, against the Point Mini system.
What is being tested?
The study tests the effectiveness of the Point Mini system over a two-month period versus one month with their usual prosthesis or assistive device. It's a crossover design where kids use both treatments at different times and are assessed on function and usage.
What are the potential side effects?
Since this trial involves a non-drug intervention (prosthetic device), traditional side effects like those seen with medications may not apply. However, potential issues could include discomfort, skin irritation, or difficulty adapting to the Point Mini.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 3 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
ABILHAND-Kids
DISABKIDS
Secondary study objectives
Weekly Diary Entries

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Point MiniExperimental Treatment1 Intervention
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.
Group II: Current/No DeviceActive Control1 Intervention
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.

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Who is running the clinical trial?

Point DesignsLead Sponsor
6 Previous Clinical Trials
52 Total Patients Enrolled
Children's Healthcare of AtlantaOTHER
167 Previous Clinical Trials
106,330 Total Patients Enrolled
~9 spots leftby Aug 2026
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