Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT04890769
Status:
TERMINATED
Last Update Posted:
2022-03-18
First Post:
2021-04-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Study of Moisture Sensor Dressing Used for Exuding Wounds
Sponsor:
Fredrik Iredahl
Organization:
Study Overview
Official Title:
Post Market Clinical Follow-up (PMCF) Study for DryMax Sensor
Status:
TERMINATED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The study is terminated by the sponsor due to poor participant recruitment and due to limited opportunity to achieve commercial gain.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Observational prospective study of the clinical use of a wound dressing with a moisture sensor for use on exuding wounds.
Detailed Description:
The PMCF study will be performed as a prospective and open study of a wound dressing with a moisture sensor on exuding wounds.
Using DryMax Sensor and the display indication - advisory only - might influence the clinician's workflow and the patient's engagement in their care. The PMCF study aims to study the use of the sensor in the clinical procedure of dressing changes in one or more healthcare settings. To study how the new product is received, and how it is used in the workflow, related to its clinical performance.
Furthermore, the aim is to gather safety-related clinical data for common harms within exudate management.
Using DryMax Sensor and the display indication - advisory only - might influence the clinician's workflow and the patient's engagement in their care. The PMCF study aims to study the use of the sensor in the clinical procedure of dressing changes in one or more healthcare settings. To study how the new product is received, and how it is used in the workflow, related to its clinical performance.
Furthermore, the aim is to gather safety-related clinical data for common harms within exudate management.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: