A Study of Optical Fusion Trans-Perineal Grid

Mayo Clinic

Status: Invitation-only

Conditions: Prostate Biopsy

Treatments: Device: Trans-Perineal Grid

Study type: Interventional

Funder types: Other

Identifiers

NCT05573048

22-003369

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

20 participants in 1 patient group

Trans-Perineal Grid for prostate interventions

Experimental group

Description:

Subjects will have the trans-perineal guide grid placed the prostate biopsy or ablation procedure.

Treatment:

Device: Trans-Perineal Grid