Amputation; Traumatic, HandNCT06501092
To Assess the Utility of the Point Mini in a Clinical Take-home Study
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 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. Read more about this study
- Who is it for?
- Ages 3 to 17 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
- 14 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2025to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Unilateral or bilateral partial hand limb differences
- Fluent in English or Spanish
- Ability to follow simple directions
- Age between 3 and 17 years
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Children's Healthcare of Atlanta
Atlanta, Georgia, 30143
Colleen Coulter, 404-785-5684, Colleen.Coulter@choa.org
Rebecca Connolly, 720-600-4753, becca@pointdesigns.com
- Not yet recruiting
Point Designs
Lafayette, Colorado, 80026
Rebecca Connolly, 720-600-4753, becca@pointdesigns.com
Levin Sliker, PhD, 720-600-4753, levin@pointdesigns.com
About this 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 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.
- 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
Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets
| Study group | Role | What they receive |
|---|---|---|
| Current/No Device | No 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. |
| Point Mini | Experimental | Outcome measurements will be performed ~60 days after the subject has been fit with a prosthesis, with additional visits occurring immediately post-fitting and ~30 days post-fitting. Receives: Device: Point Mini |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2)
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.
Measured: Baseline (pre-fitting), 60 days post-fitting
PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE)
The PROMIS Ped - UE is a questionnaire that measures upper extremity physical function specifically in children. Both self-report and parent proxy-report versions are available.
Measured: Baseline (pre-fitting), 60 days post-fitting
Secondary outcomes (1)
Weekly Diary Entries
Throughout the study, subjects and their parents will fill out weekly logs asking their experiences during the day, number of hours wearing the device, descriptions of the tasks performed, and open-response sections to clarify/detail any other events. The weekly logs will be in sealed envelopes and not opened until the completion of the study by the experimenters.
Measured: Through study completion, an average of 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study start18 Jun 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Point Designs
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Children's Healthcare of Atlanta, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Levin Sliker, PhD, Principal investigator, Point Designs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06501092
- Sponsor's protocol ID
- 445970
- Other IDs
- 4R44HD113485-02
- Status last verified
- Jun 2026
- First submitted
- 5 Jul 2024
- Last updated
- 26 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 26 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Assess the Utility of the Point Mini in a Clinical Take-home Study
- ClinicalTrials.gov ID
- NCT06501092
- Acronym / sponsor ID
- 445970
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Point DesignsIndustry (pharma, biotech, devices)
- Collaborators
- Children's Healthcare of Atlanta, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 18 Jun 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 15 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Current/No Device | No 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. |
| Point Mini | Experimental | Device: Point MiniOutcome measurements will be performed ~60 days after the subject has been fit with a prosthesis, with additional visits occurring immediately post-fitting and ~30 days post-fitting. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Unilateral or bilateral partial hand limb differences
- Fluent in English or Spanish
- Ability to follow simple directions
- Age between 3 and 17 years
Key exclusion criteria (5 listed)
- 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
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 MiniPatient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets | Device | Point Mini |
Primary outcome
Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2)
Time frame: Baseline (pre-fitting), 60 days post-fitting
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.
PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE)
Time frame: Baseline (pre-fitting), 60 days post-fitting
The PROMIS Ped - UE is a questionnaire that measures upper extremity physical function specifically in children. Both self-report and parent proxy-report versions are available.
1 secondary outcome
Weekly Diary Entries
Time frame: Through study completion, an average of 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 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.
Levin Sliker, PhD principal investigator
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 5 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: looking for participants now, as of the sponsor's last update on 26 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Connolly (720-600-4753, becca@pointdesigns.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2) (time frame: Baseline (pre-fitting), 60 days post-fitting). The study lists 2 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 26 Jun 2026.