To Assess the Utility of the Point Mini in a Clinical Take-home Study (NCT06501092) | Clinical Trial Compass
RecruitingNot Applicable
To Assess the Utility of the Point Mini in a Clinical Take-home Study
United States14 participantsStarted 2025-06-18
Plain-language 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 can participate
Age range
3 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Unilateral or bilateral partial hand limb differences
* Fluent in English or Spanish
* Ability to follow simple directions
* Age between 3 and 17 years
Exclusion Criteria:
* Patients with any unhealed wounds on their residual limb(s)
* Significant cognitive deficits as determined upon clinical evaluation
* Inability to follow simple directions
* Significant physical deficits including pain and scarring impacting the design and fitting of the Point Mini prosthesis
* Other psychosocial, personal, and medical co-morbidities expressed by the subject, family or study personnel
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2)
Timeframe: Baseline (pre-fitting), 60 days post-fitting
2
PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE)
Timeframe: Baseline (pre-fitting), 60 days post-fitting