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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 December 2024

Study information
Verified date June 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 December 2024
Est. primary completion date December 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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Recruiting NCT02543905 - The PROFILE Study: Germline Genetic Profiling: Correlation With Targeted Prostate Cancer Screening and Treatment
Recruiting NCT05698576 - TRANBERG® Transperineal MR/US Fusion Laser--Induced Thermal Therapy for Men With Prostate Cancer N/A
Recruiting NCT05358223 - Pain and Anxiety During Transrectal Prostate Biopsy N/A
Recruiting NCT04985110 - Administration of Antibiotic Prophylaxis for Transperineal Prostate Biopsy in Cipto Mangunkusumo Hospital Phase 2
Recruiting NCT02375035 - Developing a Safer and More Accurate Device for Biopsies of Suspected Prostate Cancer N/A
Not yet recruiting NCT05670691 - a Study of Combined mpMRI and PSMA PET/CT for Highly Suspicious Patients Performing Radical Prostatectomy Without Biopsy
Completed NCT03040050 - Rapid PCR to Guide Antibiotic Therapy at the Time of Prostate Biopsy N/A
Completed NCT03500432 - A Study of a New Local Anesthesia Method for Transperineal Prostate Biopsy N/A
Recruiting NCT04274725 - Men's Experience of Prostate Biopsy
Not yet recruiting NCT06183905 - Multi-parametric Ultrasound Versus Multi-parametric MRI for Prostate Cancer Detection N/A
Recruiting NCT03413137 - Comparing Transperineal to Transrectal MRI-US Fusion Prostate Biopsy N/A
Withdrawn NCT02819713 - Difference in Pain Perception by Patients With Prostate Biopsy Using Instillagel Compared With Guided Ultrasound Gel N/A

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