Recruiting

Point Mini

Sponsor:

Point Designs

Code:

NCT06501092

Conditions

Amputation; Traumatic, Hand

Amputation, Congenital

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

Interventions

Point Mini

Study Details

Brief 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.

Conditions

Amputation; Traumatic, Hand

Amputation, Congenital

Study ID

NCT06501092

Start date

Jun 18, 2025

Status verified date

Jun, 2026

Completion date

Jul 31, 2027

Anticipated

Primary completion date

Jul 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 3 - 17

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

14 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

no intervention: Current/No Device

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.

experimental: Point Mini

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.

Interventions

Point Mini

Patient is fit with the Point Mini finger prosthetic system, which consists of 1-4 ratcheting mechanical digits and mounting brackets

Primary outcome measure

  • Prosthetic Upper Extremity Functional Index - 2 (PUFI - 2) [ Time Frame: Baseline (pre-fitting), 60 days post-fitting ]
  • PROMIS Pediatric - Upper Extremity Short Form (PROMIS Ped - UE) [ Time Frame: Baseline (pre-fitting), 60 days post-fitting ]

Central Contacts and Locations

Central contacts

Rebecca Connolly

720-600-4753becca@pointdesigns.com

Levin Sliker, PhD

720-600-4753levin@pointdesigns.com

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30143

Contacts

Colleen Coulter

404-785-5684Colleen.Coulter@choa.org

Rebecca Connolly

720-600-4753becca@pointdesigns.com

More Information

Sponsor

Point Designs

Last update posted

Jun 26, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Point Designs on 2026-06-26.