WithdrawnNot Applicable

To Validate Point Mini User Needs

Stopped: Early termination of funding

United States0Started 2025-07-29

Plain-language summary

The objective of the device feasibility study will be to validate the user needs of the Point Mini system. This study will be a single group intervention model where one group of 5 children with partial-hand upper limb loss will be asked to perform several tasks. Successful completion of a task results in a fulfilled user need. Failure to complete a task results in an unfulfilled user need.

Who can participate

Age range

5 Years – 15 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: * Partial hand loss with at least index and/or middle fingers loss at the MCP level * Intact thumb with full range of motion * Fluent in English * Between the ages of 5 and 15 years Exclusion Criteria: * Patients with a residual limb that is unhealed from the amputation surgery * Unhealed wounds * Significant cognitive deficits as determined upon clinical evaluation * Significant neurological deficits as determined upon clinical evaluation * Significant physical deficits of the residual limb impacting full participation in the study as determined upon clinical evaluation * Uncontrolled pain or phantom pain impacting full participation in the study as determined upon clinical evaluation * Serious uncontrolled medical problems as judged by the project therapist

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

VAL-1

Timeframe: Day 1 (8 hours)

VAL-2

Timeframe: Day 1 (10 minutes)

VAL-3.1

Timeframe: Day 1 (10 minutes)

VAL-3.2

Timeframe: Day 1 (10 minutes)

VAL-4

Timeframe: Day 1 (10 minutes)

VAL-5

Timeframe: Day 1 (10 minutes)

VAL-6

Timeframe: Day 1 (10 minutes)

VAL-7

Timeframe: Day 1 (10 minutes)

Trial details

NCT IDNCT06504667

SponsorPoint Designs

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-07-29

View on ClinicalTrials.gov More Amputation; Traumatic, Hand trials

Plain-language summary

Who can participate

Age range

5 Years – 15 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.