Ignite Creation Date:
2024-07-17 @ 11:16 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06501092
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-05
Brief Title:
To Assess the Utility of the Point Mini in a Clinical Take-home Study
Sponsor:
Point Designs
Organization:
Point Designs
Study Overview
Official Title:
To Assess the Utility of the Point Mini in a Clinical Take-home Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this study is to evaluate the efficacy of the Point Mini system as compared to the subjects 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None