Other Clinical Trial - ScanNav Anatomy PNB FDA Data Collection Plan

Clinical Trial Summary

To gather additional training and/or validation data (recorded ultrasound scans) for ScanNav Anatomy PNB in the following categories: - Femoral Nerve (Femoral) - Interpectoral (PECS I) and pectoserratus (PECS II) - Transversus abdominis plane (TAP) - Serratus Plane (SP) - Infra-inguinal Facia Iliaca (Infra-inguinal FI) Data will be collected in the form of "scenes" (target block view) and "non-scenes" (areas adjacent to the target block view).

Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.

Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.

Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

NCT number	NCT05963230
Study type	Observational
Source	IntelligentUltrasound Limited
Contact
Status	Completed
Phase
Start date	July 1, 2023
Completion date	July 21, 2023

ScanNav Anatomy PNB FDA Data Collection Plan

Clinical Trial Summary

Clinical Trial Description

Study Design