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NCT05012657 · ClinicalTrials.gov registry record · NA
Validation of Point Partial User Needs With Partial Finger Amputees
A NA study of Amputation; Traumatic, Hand, sponsored by Point Designs.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
- 2
- Study locations
NCT05012657: Completed NA study of Amputation; Traumatic, Hand, sponsored by Point Designs.
NCT05012657 is a NA study of Amputation; Traumatic, Hand that has completed, run by Point Designs. The registered enrollment target is 5 participants, below the 22-participant average among 4 other Amputation; Traumatic, Hand trials with a reported enrollment target (77% lower). The trial reports 2 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05012657, a NA study of Amputation; Traumatic, Hand, has completed, sponsored by Point Designs.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
- 2
- Study locations
Study Summary
The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees 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.
Primary Outcome
User wears Point Partial(s) for a full day (Pass/Fail). This validation method was used to confirm the following user need of the Point Partial has been met: Point Partial shall be comfortable for a full day's use. A simple pass/fail result was recorded for each user need for each participant. An overall passing rate above 80% across all user needs and participants is considered a success. Each participant attended a single-day experimental session. A day-use prosthetic socket was fabricated and
Conditions Studied
Interventions
- DEVICE Point Partial
Study Locations (2)
Colorado
- University of Colorado Denver | Anschutz Medical Campus - Aurora
- Point Designs - Lafayette
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-11-03 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
What the finished NCT05012657 record still lists
NCT05012657 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 22-participant average among 4 other Amputation; Traumatic, Hand trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Amputation; Traumatic, Hand appearing as the primary indexed condition, and to 1 intervention - of which Point Partial is the first listed.
NCT05012657 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT05012657 about?
NCT05012657 is a clinical study titled "Validation of Point Partial User Needs With Partial Finger Amputees". The objective of the device feasibility study will be to validate the user needs of the Point Partial system. This study will be a single group intervention model where one group of 5 partial finger amputees will be asked to perform several tasks. Successful completion of a task results in a fulfill...
What is the current status of trial NCT05012657?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2020-11-03. Estimated completion is 2022-12-31.
What conditions does trial NCT05012657 study?
This clinical trial studies the following conditions: Amputation; Traumatic, Hand.
What interventions are being tested in trial NCT05012657?
The interventions under investigation include: Point Partial (DEVICE).
Who is sponsoring clinical trial NCT05012657?
This trial is sponsored by Point Designs, which has 7 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05012657 being conducted?
This trial has 2 study locations across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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