A Study of Optical Fusion Trans-Perineal Grid

Not Applicable

• Conditions: Prostate Biopsy

• Registration Number: NCT05573048
• Lead Sponsor: Mayo Clinic

Brief Summary

The purpose of this research is to evaluate a new needle guide grid utilizing Clear Guide SCENERGY - MR with a grid embedded with VisiMARKER II to autoregister and target the prostate aiding in needle placement positioning. The proceduralist can utilize this technology to find the best needle path to target within the pelvis.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-04
• Study First Submitted: 2022-10-06
• Study First Submitted QC: 2022-10-06
• Study First Posted: 2022-10-10
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-03
• Last Update Posted: 2025-03-04
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

• Scheduled for a MR guided biopsy or ablation.
• One, two, or three tumor suspicious regions identified on multiparametric MRI.
• Tolerance for anesthesia/sedation.
• Ability to give informed consent.

Exclusion Criteria

• Presence of any condition (e.g., metal implant, shrapnel) not compatible with MRI.
• History of other primary non-skin malignancy within previous three years.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Needle placement accuracy	Baseline	Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and

Trial Locations

Locations (1)

Mayo Clinic Minnesota; 🇺🇸 Rochester, Minnesota, United States