Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Kidney Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Patient having procedure without PercuNav Guidance information

Biopsy procedure aided with use of PercuNav

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

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. To assess this, physicians will perform ablation procedures with and without the Percu Nav device. Data will be collected on the angle of needle entry unassisted and then assisted by PercuNAv to determine if the added imaging information modifies the physician's needle approach.

Each patient will have a pre-procedure CT image set of the area of interest acquired. The patient will be scanned in the same position that the ablation will be performed in, although not requisite. Sterile registration patches will be applied to the patient's skin around the area of interest prior to the scan, ensuring that suitable windows are left available for needle entry. The patient will undergo these pre-procedural scans as part of the usual clinical evaluation of the lesion to undergo ablation. The scans may be acquired with or without contrast, at the discretion of the physician.

Control group: The physician will perform the procedure using the standard of care method (CT only), without the additional information being recorded by the PercuNav device. The tracking device will be placed on the patient's skin at the desired point of entry. Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path. At the point of insertion, the time stamp will be recorded and the start button will be pressed. Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded by pushing the start button again. At the end of the procedure a verification CT scan will be taken with the needle in place and sent to the PercuNav.

Percu Nav group: The physician will perform the procedure using the standard of care procedure with the additional information displayed and recorded by the PercuNav device (CT and PercuNav). The tracking device will be placed on the patient's skin at the desired point of entry. Without displaying the PercuNav screen to the physician, a screen capture will be taken to record the approach path. The physician will be shown the PercuNav screen and will correct the desired approach path and another screen capture will be taken. At the point of insertion, the time stamp will be recorded and the start button will be pressed. Once the physician states they are at the defined target a screen capture will be taken on the PercuNav and the distance to target and time stamp will be recorded. At the end of the procedure a verification CT scan will be taken (as is part of the regular standard of care procedure) with the needle in place and sent to the PercuNav.

The outcome measures that will be evaluated in the groups include:

1. Accuracy - The distance between the "virtual" needle position (tracking data) and the actual needle position (CT confirmation scan)), where applicable (TRE)
2. Time to reach a clinically acceptable target in the tumor
3. The total procedure time
4. 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)

Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study

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

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)

Philips Healthcare

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Kidney lesions treated with cryoablation.

Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Cryoablation

Stephen Savage, MD

Peter Clark, MD

TRACE is an observational, open-label, single-arm, multi-center registry of subjects who have undergone renal lesion cryoablation per their physician's standard of care. Patients 18 years of age or older who have been determined to be an appropriate candidate for cryoablation will be offered enrollment into the registry. Subjects will be observed for five years from the date of their cryoablation procedure.

The registry is non-interventional; it will neither direct the cryoablation procedures performed nor define the post-surgery follow-up of each subject. A subject's participation in the registry will not influence or direct subject treatment procedures or follow-up care. Physicians will use their discretion and personal standards of care to select subjects, perform the cryoablation procedures and define appropriate follow-up visit schedules for their subjects; it is anticipated that subjects will be seen at least once per year during the five-year follow-up period of TRACE. Subjects may be followed by the physician performing the cryoablation procedure or by their local/personal physician. The enrolling physician will be responsible for providing the follow-up data to the registry and will, as appropriate, work with a subject's local/personal physician to collect the follow-up data.

Tracking Renal Tumors After Cryoablation Evaluation

Tracking Renal Tumors After Cryoablation Evaluation (TRACE) Registry

Changes to lesion size using greatest trans-axial diameter (cm) from baseline through the follow-up intervals.

Determined by the estimated Median Glomerular Filtration Rate (eGFR) measure using mL/min

Length of time in hospital is the duration of the patient's in-hospital time measured in hours, from intervention to discharge with the average duration of hospitalization being 2 days but could be much longer.

Lesions with imaging that showed contrast enhancement based on investigator assessment.

Disease-specific survival rate is the time in days from cryoprocedure to death due to kidney cancer. Subjects who are alive will be censored at date of their last visit. Subjects who have died from causes other than kidney cancer will be censored at the time of death. Patients are followed up for duration of registry which is 5 years.

QoL SF12 is a health status survey to monitor outcomes in general and specific populations. Scoring system for the SF12 is norm-based scoring (NBS). This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health. Scale range (min-max,range): GH 23.9-63.7,39.8; PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9; BP 21.7-57.7,36.1; VT 29.4-68.7, 39.4; SF 21.3-56.9,35.6; RE 14.7-56.3,41.6; HM 18.3-64.2,45.9; PCS 9.9-76,66 MCS 3.2-77.9,74.7

Time between cryotherapy and first evidence of metastatic disease

Total recurrences based on imaging with enhancement and retreatments (eg: nephrectomy, partial nephrectomy or ablation).

An assessment of outcomes across laparoscopic-assisted, percutaneous and open cryoablation procedures.

Characterization of standards of care for cryoablation procedure follow-up across the participating registry centers.

Boston Scientific Corporation

Potentially and directly related cryoablation AEs, SAEs/UADEs

Kidney lesions treated with cryoablation.

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

There were a total of 246 ITT patients with 145 patients having lesions biopsied and proven Renal Cell Carcinoma (RCC).

Kidney Lesions Amenable to Cryoablation [ITT Population]

Participants with kidney lesions treated with cryoablation.

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Lesion size measured by greatest trans-axial diameter (cm)

Lesion Size

General Health

Physical Functioning

Role Physical

Bodily Pain

Vitality

Social Functioning

Mental Health

Role Emotional

Physical Component Summary

Mental Component Summary

QoL SF12 is a health status survey to monitor outcomes in general and specific populations. Scoring system for the SF12 is norm based scoring (NBS).This rescaling is done by linear transformation.The scale for each component is provided where the min = worst health and max= best health. Scale range (min-max,range) : GH 23.9-63.7,39.8; PF 25.6-57.1,31.5 ; RP 23.6-57.5, 33.9 ; BP 21.7-57.7,36.1 ; VT 29.4-68.7, 39.4 ; SF 21.3-56.9,35.6; RE 14.7-56.3,41.6; HM 18.3-64.2,45.9;PCS 9.9-76,66 MCS 3.2-77.9,74.7

Quality of Life (QOL) Over time as assessed by the Short Form-12 (SF-12) GM

Chantal Laframboise, Clinical Research Manager

Baseline

Month 6

Month 12

Month 24

Month 36

Month 48

Month 60

Patient with kidney lesions treated with cryoablation.

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance.

There were a total of 246 ITT patients with 145 patients had biopsy proven Renal Cell Carcinoma (RCC).

Participants for whom cryoablation via GALIL Medical Cryoablation system was performed with available data at the respective time point.

Changes in Lesion Size

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

Renal Function Status

Hospital Stay

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

There were a total of 246 ITT participants out of that 145 participants had lesion biopsy with proven Renal Cell Carcinoma (RCC).

Post-cryoablation Lesion Recurrence With Enhancement

Disease-specific Survival Rates

Overall Survival Rates

General Health at month 6

General Health at month 12

Physical Functioning at month 6

Physical Functioning at month 12

Role Physical at month 6

Role Physical at month 12

Bodily Pain at month 6

Bodily Pain at month 12

Vitality at month 6

Vitality at month 12

Social Functioning at month 6

Social Functioning at month 12

Mental Health at month 6

Mental Health at month 12

Role Emotional at month 6

Role Emotional at month 12

Physical Component Summary at month 6

Physical Component Summary at month 12

Mental Component summary at month 6

Mental Component summary at month 12

Quality of Life Assessment

Development of Metastatic Disease.

Total Number of Recurrences

Procedure Method: Laparoscopic

Procedure Method: Percutaneous

Procedure Method: Open

Number of lesions treated with cryoablation is One

Number of lesions treated with cryoablation is Two

Number of lesions treated with cryoablation is Three

Type of hemostatic agents or maneuvers used is None

Type of hemostatic agents or maneuvers used=Compression

Type of hemostatic agents or maneuvers used=Suturing

Type of hemostatic agents or maneuvers used=Floseal

Type of hemostatic agens or maneuvers used=Surgical

Type of hemostatic agents or maneuversed used=Other

Method of monitoring iceball formation=CT

Method of monitoring iceball formation=Ultrasound

Number of freeze/thaw cycles=0*

Number of freeze/thaw cycles=2

Number of freeze/thaw cycles=3

Number of freeze/thaw cycles=4

Complications (malfunction of cryoablation system)

Intra-operative patient complications

Cryoablation: Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance

There were a total of 246 ITT participants with 145 of those having lesion(s) with biopsy proven Renal Cell Carcinoma (RCC).

INTENT TO TREAT (ITT)- POPULATION

RENAL CELL CARCINOMA (RCC) POPULATION

Participants treated with laparoscopic, percutaneous, or open procedure.

Procedure Method Outcomes

Disease free=Yes

Disease free=No

Disease free=Indeterminate

New therapies for renal cancer (patient specific)=Yes

New therapies for renal cancer (patient specific)=Yes [Local]

New therapies for renal cancer (patient specific)=Yes [Systemic]

New thereapies for renal cancer (patient specific)=No

ITT Population

RCC Population

Is participant disease free (renal specific?) Are there new therapies for renal cancer (patient specific)

Standard of Care Follow-up Procedures

Overall Study

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

single arm, open label, treatment; ProSenseTM Cryoablation treatment, post marketing surveillance

single arm, open label, PROSENSE™ treatment

PROSENSE™

Halachmi Sarel, Prof.

This experiment is designed for post marketing data collection of a cryosurgical system \[PROSENSE™ of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).

A post marketing data collection of a cryosurgical system \[PROSENSE™\] of IceCure Medical\], for the treatment of renal cell carcinoma (RCC).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Electromagnetic Tracking of Devices During Interventional Procedures - A Cryoablation Study	NCT01401777	Kidney Tumors		18 Years - 100 Years	Philips Healthcare
Tracking Renal Tumors After Cryoablation Evaluation	NCT01117779	Kidney Neoplasm...	Cryoablation	18 Years -	Boston Scientific Corporation
Post Marketing Surveillance for PROSENSE™ a Cryotherapy Treatment of Renal Cell Carcinoma	NCT02399124	Renal Cell Carc...	PROSENSE™	18 Years -	IceCure Medical Ltd.

Spots Global Cancer Trial Database for kidney tumors