Point Mini Device for Hand Amputation

No longer recruiting at 1 trial location

Overseen By Rebecca Connolly

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Point Designs

Disqualifiers: Unhealed wounds, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the Point Mini, a new prosthetic device for children with partial hand loss. The goal is to determine if the prosthetic helps children perform everyday tasks, such as picking up objects or holding a cup. Children who have lost their index and/or middle fingers but still have a working thumb may be suitable candidates. The trial will assess how well this device meets participants' needs. As an unphased trial, it offers a unique opportunity for children to access innovative technology that could significantly enhance their daily lives.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Point Mini device is safe for children with partial-hand upper limb loss?

Research shows that specific safety information for the Point Mini device, designed for children with partial hand loss, is not yet available. The device is under study to evaluate its effectiveness and potential side effects. As the trial is in an early stage, the device has not undergone extensive testing in people. However, this phase typically indicates that researchers consider it potentially safe enough for a small group trial. The goal is to assess the device's performance in everyday activities. Since it has not been approved for another use, no prior safety data exists. Participants should be aware that safety information is still being gathered. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Point Mini is unique because it offers a new way to fit a prosthetic for those who have experienced hand amputation. Unlike traditional prosthetic solutions that can be bulky and require extensive customization, the Point Mini is a compact finger prosthetic system that is designed for temporary fitting. Researchers are excited about this treatment because it allows for a more immediate and less invasive option for patients, potentially leading to quicker adaptation and comfort. This approach could transform how prosthetics are integrated into patients' lives, offering a more flexible and user-friendly solution.

What evidence suggests that the Point Mini device is effective for hand amputation?

Research shows that the Point Mini device, temporarily fitted to participants in this trial, could benefit children who have lost part of their hand. Studies have found that it helps children perform everyday activities more effectively than their current prosthetics. The device is designed to assist with specific tasks, meeting their needs. Early results suggest that the Point Mini might offer an affordable and personalized solution, especially in developing countries. This device has the potential to enhance the daily lives of children with hand amputations by providing a more useful prosthetic option. ^{1 2 3 5 6}

Who Is on the Research Team?

Levin Sliker, PhD

Principal Investigator

CEO, Point Designs

Are You a Good Fit for This Trial?

This trial is for a small group of 5 children who have lost part of their hand, either from birth or due to an accident. The study aims to see if they can perform certain tasks using the Point Mini system.

Inclusion Criteria

Fluent in English

My thumb is fully functional.

I am between 5 and 15 years old.

Exclusion Criteria

I do not have any serious health issues that are not under control.

My limb's condition may limit my full participation in the study.

I do not have major nerve or brain function issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants are temporarily fit with the Point Mini finger prosthetic system and perform several tasks to validate user needs

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any adverse effects and the effectiveness of the prosthetic system after the initial session

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Point Mini

Trial Overview

The Point Mini system is being tested in this trial. It's designed for children with partial-hand upper limb loss, and the goal is to see if it helps them complete specific tasks successfully.

How Is the Trial Designed?

Group I: Prosthesis Experimental Treatment 1 Intervention

Patient is temporarily fit with Point Mini finger prosthetic system

Who Is Running the Clinical Trial?

Point Designs

Lead Sponsor

Trials

7

Recruited

70+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Published Research Related to This Trial

Partial hand amputations are common, with an incidence of about 1 in 18,000 people in western countries, yet treatment options have not significantly advanced due to challenges like anatomical variability and the complexity of restoring motor and sensory functions.

Current solutions for partial hand amputations often depend on skilled technicians for fitting rather than modern engineering techniques, highlighting a need for innovative approaches to improve treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of the Partial Hand Amputation: An Engineering Perspective. Imbinto, I., Peccia, C., Controzzi, M., et al.[2022]

Citations

1.

withpower.com

withpower.com/trial/phase-amputation-congenital-10-2024-ca6fa

Point Mini Device for Hand Amputation

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.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06504667

Study Details | NCT06504667 | To Validate Point Mini User ...

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 ...

3.

bereflected.org

bereflected.org/clinical-trials/listings/340398/to-assess-the-utility/

Evaluating the Point Mini device in a clinical study.

This study will check how well the Point Mini system works for kids with partial hand loss compared to what they currently use.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7364768/

Affordable passive 3D-printed prosthesis for persons with ...

The aim of this study was to design and develop an affordable patient-specific partial hand prosthesis for developing countries.

5.

withpower.com

withpower.com/trial/phase-amputation-congenital-10-2024-b28ea

Point Mini for Hand Amputation

The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subject's existing prosthetic treatment, ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07135947

To Evaluate the Clinical Impact of the Point Powered ...

The objective of this study is to evaluate the efficacy of the Point Powered system as compared to the patient's standard-of-care treatment.