Trials / Completed
CompletedNCT05190354
Post Market Clinical Protocol - Xtremity Polymer Prosthetic Socket System
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (actual)
- Sponsor
- Medical Creations, Inc. · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
Single-arm, prospective multi-center study assessing user preference of the Xtremity prosthetic socket in below the knee amputation prostheses.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Xtremity Polymer Prosthetic Socket | Subjects with transtibial unilateral or bilateral amputation who have experience using a standard carbon fiber or high temperature thermoplastic prosthetic socket will be evaluated and fitted with a below knee prosthesis socket |
Timeline
- Start date
- 2021-11-16
- Primary completion
- 2022-05-11
- Completion
- 2022-06-24
- First posted
- 2022-01-13
- Last updated
- 2022-08-24
Locations
2 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05190354. Inclusion in this directory is not an endorsement.