Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
Study NCT ID:
NCT04277169
Status:
COMPLETED
Last Update Posted:
2021-02-17
First Post:
2020-01-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide
Sponsor:
IntelligentUltrasound Limited
Organization:
Study Overview
Official Title:
A Volunteer Study to Collect Imaging Data for the Development of the IntelligentUltrasound Anatomy Guide
Status:
COMPLETED
Status Verified Date:
2021-02
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 is a single-centre, prospective, non-randomised volunteer study to be undertaken in the MediCentre, Heath Park, Cardiff, UK
Detailed Description:
This is a single-centre, non-randomised, prospective study involving at least 120 participants. The data collected in this study will augment the data collected in IU2019\_AG\_03 Volunteers will be enrolled sequentially until at least 120 scans have been recorded. Ideally, between 120 and 150 scans will be recorded.
Phase I Data collected from up to the first 80 participants in each of the six peripheral nerve block areas will be used as a training/verification set. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images.
Phase II The remaining 40 videos in each area (total minimum 120 participants) will be used for validation of these models.
The validation videos will be fed into the models created during Phase I of the study and the output anatomy highlighting will be recorded as a separate video, overlaid on the original ultrasound image. The overlay video will then be further split into 30-second segments.
A panel of three independent expert anaesthetists will be convened to review and score the segments for accuracy and performance to the endpoints agreed in Phase I of the study.
Phase I Data collected from up to the first 80 participants in each of the six peripheral nerve block areas will be used as a training/verification set. This set will be used to develop and verify models for the identification and highlighting of target anatomical structures on ultrasound images.
Phase II The remaining 40 videos in each area (total minimum 120 participants) will be used for validation of these models.
The validation videos will be fed into the models created during Phase I of the study and the output anatomy highlighting will be recorded as a separate video, overlaid on the original ultrasound image. The overlay video will then be further split into 30-second segments.
A panel of three independent expert anaesthetists will be convened to review and score the segments for accuracy and performance to the endpoints agreed in Phase I of the study.
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?: