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NCT06504667 | RECRUITING | Amputation; Traumatic, Hand

To Validate Point Mini User Needs
Sponsor:

Point Designs

Brief 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.

Condition or disease

Amputation; Traumatic, Hand

Amputation, Congenital

Intervention/treatment

Point Mini

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 5 participants
Masking : NONE
Primary Purpose : DEVICE_FEASIBILITY
Official Title : To Validate Point Mini User Needs
Actual Study Start Date : 2025-06-30
Estimated Primary Completion Date : 2025-10-03
Estimated Study Completion Date : 2025-10-03

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 5 Years to 15 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
To Validate Point Mini User Needs

Location Details

NCT06504667

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Colorado

University of Colorado Denver | Anschutz Medical Campus

Aurora, Colorado, United States, 80045

ACTIVE NOT RECRUITING

United States, Colorado

Point Designs

Lafayette, Colorado, United States, 80026