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NCT05573048 Clinical Trial

A Study of Optical Fusion Trans-Perineal Grid

Prostate Biopsy Clinical Trial

Official title:
Optical Fusion Trans-Perineal Grid

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT05573048
Other study ID # 22-003369
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date October 4, 2022
Est. completion date May 2024

Study information
Verified date April 2024
Source Mayo Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 20
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• Trans-Perineal Grid
A small square piece of plastic with many holes in it placed between the legs to help guide the path of the interventional instruments and to facilitate the prostate intervention. The guide grid will help with needle placement using the grid technology.

Locations
Country Name City State
United States Mayo Clinic Minnesota Rochester Minnesota

Sponsors (2)
Lead Sponsor Collaborator
Mayo Clinic Clear Guide Medical Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Needle placement accuracy Number of needle placements to successfully match target and needle tip position assessed by direct MR imaging and Baseline
See also
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