Amputation; Traumatic, HandNCT06504667
To Validate Point Mini User Needs
A study testing Point Mini in people with Amputation; Traumatic, Hand and Amputation, Congenital, run by Point Designs at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Amputation; Traumatic, Hand, Amputation, Congenital
- What is being tested?
- Point Mini
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Jul 2025to 29 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Colorado Denver | Anschutz Medical Campus
Aurora, Colorado, 80045
Point Designs
Lafayette, Colorado, 80026
About this study
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.
- Being tested
- Point Mini
- Medical subject headings
- Amputation, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point MiniDevice
The Point Mini finger prosthetic system consists of 1-4 ratcheting mechanical digits and mounting brackets
| Study group | Role | What they receive |
|---|---|---|
| Prosthesis | Experimental | Patient is temporarily fit with Point Mini finger prosthetic system Receives: Device: Point Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAL-1
User wears Point Mini(s) for a entire session without discomfort (Pass/Fail)
Measured: Day 1 (8 hours)
VAL-2
User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail)
Measured: Day 1 (10 minutes)
VAL-3.1
User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail)
Measured: Day 1 (10 minutes)
VAL-3.2
User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail)
Measured: Day 1 (10 minutes)
VAL-4
User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail)
Measured: Day 1 (10 minutes)
VAL-5
User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail)
Measured: Day 1 (10 minutes)
VAL-6
User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail)
Measured: Day 1 (10 minutes)
VAL-7
User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail)
Measured: Day 1 (10 minutes)
VAL-8
User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail)
Measured: Day 1 (10 minutes)
VAL-9
User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail)
Measured: Day 1 (8 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2024
- Study start29 Jul 2025
- Primary completion29 Jul 2025
- Study completion29 Jul 2025
Why it stopped: Early termination of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation; Traumatic, HandStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Point Designs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Levin Sliker, PhD, Principal investigator, CEO, Point Designs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504667
- Sponsor's protocol ID
- 445969
- Other IDs
- 4R44HD113485-02
- Status last verified
- Jun 2026
- First submitted
- 10 Jul 2024
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Validate Point Mini User Needs
- ClinicalTrials.gov ID
- NCT06504667
- Acronym / sponsor ID
- 445969
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Early termination of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Point DesignsIndustry (pharma, biotech, devices)
- Collaborators
- University of Colorado, Denver, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 29 Jul 2025 (actual)
- Primary completion
- 29 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 17 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prosthesis | Experimental | Device: Point MiniPatient is temporarily fit with Point Mini finger prosthetic system |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Point MiniThe Point Mini finger prosthetic system consists of 1-4 ratcheting mechanical digits and mounting brackets | Device | Prosthesis |
Primary outcome
VAL-1
Time frame: Day 1 (8 hours)
User wears Point Mini(s) for a entire session without discomfort (Pass/Fail)
VAL-2
Time frame: Day 1 (10 minutes)
User flexes and extends the Point Mini(s) without using contralateral hand ten times (Pass/Fail)
VAL-3.1
Time frame: Day 1 (10 minutes)
User lifts a 10-25 lb bag with Point Mini(s) depending on age (Pass/Fail)
VAL-3.2
Time frame: Day 1 (10 minutes)
User grips a hammer with Point Mini(s) and makes indentations into the wood (Pass/Fail)
VAL-4
Time frame: Day 1 (10 minutes)
User releases Point Mini(s) while performing an active grasp by pressing the dorsal button ten times sequentially (Pass/Fail)
VAL-5
Time frame: Day 1 (10 minutes)
User positions Point Mini(s) into each of the locking positions without binding (Pass/Fail)
VAL-6
Time frame: Day 1 (10 minutes)
User activates spring-back mechanism ten times without failure by using (1) contralateral hand, (2) tabletop, and (3) side or thigh (Pass/Fail)
VAL-7
Time frame: Day 1 (10 minutes)
User grips a 5 lb cylindrical smooth object using Point Mini(s) for 10 seconds (Pass/Fail)
VAL-8
Time frame: Day 1 (10 minutes)
User picks up 4 coins from a smooth tabletop within 30 seconds (Pass/Fail)
VAL-9
Time frame: Day 1 (8 hours)
User performs VAL-1 through VAL-8 without Point Mini releasing from mounting system (Pass/Fail)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Levin Sliker, PhD principal investigator
CEO, Point Designs
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point Mini in people with Amputation; Traumatic, Hand and Amputation, Congenital, run by Point Designs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAL-1 (time frame: Day 1 (8 hours)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.