Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05960591
Status:
RECRUITING
Last Update Posted:
2024-04-18
First Post:
2023-07-07
Brief Title:
Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures
Sponsor:
SLAM Ortho BV
Organization:
SLAM Ortho BV
Study Overview
Official Title:
Usability of the ADEPTH Sensor for Bore Depth Measurements in Plate Osteosynthesis Procedures a Monocenter Randomized Pilot Study
Status:
RECRUITING
Status Verified Date:
2024-04
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:
ADEPTH-Pilot
Brief Summary:
The goal of this monocenter randomized pilot study is to investigate the usability of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures The main question it aims to answer is
- What is the usability score of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures Participants will receive either bore depth measurements with the ADEPTH sensor or with the manual depth gauge
- What is the usability score of the ADEPTH sensor for bore depth measurements during plate osteosynthesis procedures Participants will receive either bore depth measurements with the ADEPTH sensor or with the manual depth gauge
Detailed Description:
To assess the usability score of the ADEPTH sensor for bore depth measurements in plate osteosynthesis procedures The surgeon and OR-assistant will fill in one survey after performing 3 operations with the ADEPTH sensor and one survey after performing 3 operations with the manual depth gauge
Study Oversight
Has Oversight DMC:
None
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?:
None