Ignite Creation Date:
2025-12-24 @ 1:59 PM
Ignite Modification Date:
2026-02-20 @ 10:08 PM
Study NCT ID:
NCT00405795
Status:
COMPLETED
Last Update Posted:
2008-07-04
First Post:
2006-11-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Envision® Surface Evaluation
Sponsor:
Hill-Rom
Organization:
Study Overview
Official Title:
Envision® Surface Evaluation for Patients With Stage II, Stage III, or Stage IV Pressure Ulcers
Status:
COMPLETED
Status Verified Date:
2008-07
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:
This observational study will acquire initial clinical practice utilization and product safety data for the Envision® surface.
Detailed Description:
This is a single site, open label, observational study to acquire initial clinical practice utilization information, product safety, and wound healing data, as defined by changes in wound volume and/or surface area, for patients with pressure ulcers placed on this surface.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: