ScanNav Anatomy PNB Data Collection Study
Sponsor
IntelligentUltrasound Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05992805
Collaborator
(none)
40
1
9.3
4.3
Study Details
Study Description
Brief Summary
Study to gather additional data for AI-driven medical device, ScanNav Anatomy PNB.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Volunteer study to gather additional ultrasound training and/or validation data for Artificial Intelligence (AI)-algorithms used in the medical device ScanNav Anatomy PNB.
Study Design
Study Type:
Observational
Anticipated Enrollment
:
40 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
ScanNav Anatomy PNB Data Collection Study
Actual Study Start Date
:
Mar 22, 2023
Anticipated Primary Completion Date
:
Dec 31, 2023
Anticipated Study Completion Date
:
Dec 31, 2023
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Volunteer Participants Volunteer participants being scanned by a qualified clinician using various ultrasound machines. |
Other: N/A - non-interventional study
N/A - non-interventional study. Data collection only.
|
Outcome Measures
Primary Outcome Measures
- Training and/or validation data (in the form of recorded ultrasound scans) [6 months]
Ultrasound scans to be used for training and/or validation of AI models developed in-house to assist ultrasound-guided regional anaesthesia.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
-
Male or female, at least 18 years of age;
-
Able to comprehend and sign the Informed Consent prior to enrolment in the study.
Exclusion Criteria:
-
Aged <18 years of age;
-
Unwilling or unable to provide informed consent.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hodge House | Cardiff | United Kingdom | CF10 1DY |
Sponsors and Collaborators
- IntelligentUltrasound Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
IntelligentUltrasound Limited
ClinicalTrials.gov Identifier:
NCT05992805
Other Study ID Numbers:
- IU2023_AG_11
First Posted:
Aug 15, 2023
Last Update Posted:
Aug 15, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No