Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-24 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT07046832
Description:
The trial evaluates a novel augmented reality needle guidance platform that includes investigational software features and procedural performance data. These elements are considered proprietary and form part of an active product development that may be incorporated as part of a broader regulatory strategy.
In addition, the study's small sample size and highly structured procedural metrics - including EM tracking outputs, intraoperative timing, and device-specific workflow parameters - increase the risk of participant re-identification, even without direct identifiers or imaging.
To protect intellectual property and ensure compliance with HIPAA, GDPR, and FDA confidentiality provisions (21 CFR § 812.38; 21 CFR § 20.61), individual participant data (IPD) will not be shared. Summary-level data and aggregate results will be made available through peer-reviewed publications and posted on ClinicalTrials.gov
Study:
NCT07046832
Study Brief:
Clinical Evaluation of an Augmented Reality Intraprocedural Needle Guidance Platform for Soft Tissue Biopsy