Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study

NCT01401777 | Withdrawn

• 1 other identifier: 2010_CRYO_V7
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to assess and quantify any differences between assisted (using real-time visualization of tracked cryo-probes) and unassisted cryoablation procedures using pre-procedure CT scans or CT fluoroscopy with respect to: Primary Endpoint:

• "TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position (CT confirmation scan)) Secondary Endpoints
• Accuracy of needle targeting - The vector of each needle insertion (The initial vector allows us to project the path to the pre-defined target. If the initial entry point is not ideal, the path to the target will need adjustment) Based on a two-sample t-test (significance level of 0.05, two-tailed), the study has 89% power to detect a difference of 2mm in accuracy between the two treatment groups (assuming a standard deviation of 1.9mm).
• Measure time difference between assisted and unassisted procedure

Conditions

Kidney Tumors

Keywords

Kidney Tumors, Cryoablation, Biopsy

Outcome Measures

Primary Outcomes (1)

• Target Registration Error

  "TRE" Target Registration Error (distance between "virtual" needle position (tracking data) and the actual needle position (CT confirmation scan))

  24 hrs

Secondary Outcomes (1)

• Accuracy of needle targeting

  24 hrs

Study Arms (2)

Control, No PercuNav

Patient having procedure without PercuNav Guidance information

PercuNav aided procedure

Biopsy procedure aided with use of PercuNav

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Promary Care Clinic

You may qualify if:

• Has had a pre-operative CT/MRI scan performed and will be undergoing an ablation procedure of the kidney;
• Is over the age of 18;
• Has the ability to understand and the willingness to sign a written informed consent form, and complies with the protocol;
• Has the ability to follow procedural instructions, including, but not limited to, holding their breath and remaining reasonably motionless during the procedure.

Sponsors & Collaborators

• Philips Healthcare: lead

Study Sites (1)

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2011
• First Posted: July 25, 2011
• Study Start: December 1, 2014
• Primary Completion: May 1, 2015
• Study Completion: December 1, 2015
• Last Updated: April 27, 2021

Record last verified: 2021-04

Locations

US (1)