Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy

• Sponsor: Indiana Kidney Stone Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00351351
• Collaborator: (none)
• Enrollment: 70
• Locations: 7
• Arms: 2
• Duration (Months): 22
• Patients Per Site: 10
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

Percutaneous nephrolithotomy (PNL), in conjunction with intracorporeal lithotripsy, allows for the rapid removal of any kidney stone regardless of size. Currently, the choice of intracorporeal lithotripters includes ultrasonic, pneumatic, and combined ultrasonic/pneumatic energy sources. Recently, a novel dual probe design as been introduced by Cybersonics of Erie, Pennsylvania. This dual probe intracorporeal lithotrite is called the Cyberwand, and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Condition or Disease	Intervention/Treatment	Phase
Kidney Stones	Device: Cyberwand; Device: single probe ultrasonic	N/A

Detailed Description

Percutaneous nephrolithotomy (PNL) is used to remove large and complex stones from the upper urinary tract. Intracorporeal lithotripsy is an integral part of PNL. Commercially available intracorporeal lithotripsy modalities include ultrasonic, pneumatic, and combined ultrasonic and pneumatic models. Each modality has its inherent advantages and disadvantages. Ultrasonic lithotrites are capable of fragmenting stones while concomitantly suctioning out fragments. Unfortunately some stones are hard enough to resist fragmentation from ultrasonic lithotripsy. Pneumatic lithotrites are able to fragment all stones regardless of hardness, but this modality is unable to suction out stone pieces at the same time fragmentation is occurring. The newest lithotrite which combines both ultrasonic and pneumatic components is capable of fragmenting any stone, but also has some inherent limitations. The handpiece of the lithotripsy device is somewhat cumbersome, the suction component can clog, and the device has overheated at the maximal settings (Kuo et al). Current intracorporeal lithotrites, while functional, can certainly be improved.

Recently, a novel dual probe design has been introduced by Cybersonics of Erie, PA. This dual probe intracorporeal lithotrite is called the Cyberwand and is composed of a fixed inner probe vibrating at an ultrasonic frequency with an outer probe vibrating at about 1,000 Hz. As this new design has the potential to revolutionalize intracorporeal lithotripsy, we intend to compare this novel technology to currently available lithotripsy technology in a randomized clinical trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Control Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy
• Study Start Date: Jul 1, 2006
• Actual Primary Completion Date: May 1, 2008
• Actual Study Completion Date: May 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: A Cyberwand	Device: Cyberwand; FDA approved - dual probe intracorporeal lithotrite
Active Comparator: B Currently available lithotripsy technology	Device: single probe ultrasonic; FDA-approved - single probe ultrasonic

Outcome Measures

Primary Outcome Measures

1. Kidney Stone Clearance Rate [6 months]

   stone clearance rate calculated in mm^2/min per protocol specification

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patient of Methodist Urology in Indianapolis, IN

• Undergoing percutaneous nephrolithotomy for calculi greater than 2 cm

• Age 18 years or older

• Stone easily visible/measurable on kidney, ureters and bladder (KUB) or computed tomography (CT) scan preoperatively

Exclusion Criteria:

• Radiolucent stones

• Size of largest stone less than 2 cm

• Pregnancy

• Inability to give informed consent

• Multiple percutaneous access anticipated

• Active urinary tract infection

• Recent (within last 3 months) extracorporeal shock wave lithotripsy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University Dept. of Urology	Chicago	Illinois	United States	60611
2	Methodist Hospital	Indianapolis	Indiana	United States	46202
3	John's Hopkins University	Baltimore	Maryland	United States
4	Duke University	Durham	North Carolina	United States	27710
5	University of Wisconsin	Madison	Wisconsin	United States	53792
6	Vancouver Hospital	Vancouver	British Columbia	Canada
7	University of Western Ontario - St. Joseph's Hospital	London	Ontario	Canada

Sponsors and Collaborators

• Indiana Kidney Stone Institute

Investigators

• Principal Investigator: James E. Lingeman, MD, Methodist Urology

Study Documents (Full-Text)

None provided.

More Information

Publications

• Kuo RL, Paterson RF, Siqueira TM Jr, Evan AP, McAteer JA, Williams JC Jr, Lingeman JE. In vitro assessment of lithoclast ultra intracorporeal lithotripter. J Endourol. 2004 Mar;18(2):153-6.

• Responsible Party: Indiana Kidney Stone Institute
• ClinicalTrials.gov Identifier: NCT00351351
• Other Study ID Numbers: 06-035
• First Posted: Jul 12, 2006
• Last Update Posted: Mar 30, 2017
• Last Verified: Feb 1, 2013

• Keywords provided by Indiana Kidney Stone Institute: Kidney Stones; Renal Calculi
• Additional relevant MeSH terms: Kidney Calculi; Nephrolithiasis

Study Results

Participant Flow

Recruitment Details	Patients undergoing percutaneous nephrolithotomy with a target stone size greater than 2cm

Arm/Group Title	Cyberwand	Currently Available Lithotripsy Technology
Arm/Group Description	Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite	Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic
Period Title: Overall Study
STARTED	34	36
COMPLETED	25	32
NOT COMPLETED	9	4

Baseline Characteristics

Arm/Group Title	Cyberwand	Currently Available Lithotripsy Techology	Total
Arm/Group Description	Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite	Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic	Total of all reporting groups
Overall Participants	34	36	70
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	28 82.4%	31 86.1%	59 84.3%
>=65 years	6 17.6%	5 13.9%	11 15.7%
Sex: Female, Male (Count of Participants)
Female	14 41.2%	14 38.9%	28 40%
Male	20 58.8%	22 61.1%	42 60%
Region of Enrollment (participants) [Number]
United States	24 70.6%	26 72.2%	50 71.4%
Canada	10 29.4%	10 27.8%	20 28.6%

Outcome Measures

1. Primary Outcome

Title	Kidney Stone Clearance Rate
Description	stone clearance rate calculated in mm^2/min per protocol specification
Time Frame	6 months

Outcome Measure Data

Analysis Population Description

Sample size calculations were performed using a two-sided Student's t-test with a power of 90% and a significance level of α = 0.05

Arm/Group Title	Cyberwand	Currently Available Lithotripsy Techology
Arm/Group Description	Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite	Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic
Measure Participants	25	32
Mean (Full Range) [mm^2/min]	61.9	75.8

Adverse Events

Arm/Group Title	Cyberwand		Currently Available Lithotripsy Technology
Arm/Group Description	Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite		Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic
All Cause Mortality
	Cyberwand		Currently Available Lithotripsy Technology
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Cyberwand		Currently Available Lithotripsy Technology
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/34 (0%)		0/36 (0%)
Other (Not Including Serious) Adverse Events
	Cyberwand		Currently Available Lithotripsy Technology
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	10/34 (29.4%)		15/36 (41.7%)
Gastrointestinal disorders
ileus	1/34 (2.9%)	1	0/36 (0%)	0
General disorders
persistent flank pain	1/34 (2.9%)	1	0/36 (0%)	0
Infections and infestations
fever	0/34 (0%)	0	3/36 (8.3%)	3
Renal and urinary disorders
hydronephrosis	0/34 (0%)	0	1/36 (2.8%)	1
perinephric haematoma	1/34 (2.9%)	1	0/36 (0%)	0
discharged home with nephrostomy tube	4/34 (11.8%)	4	7/36 (19.4%)	7
Respiratory, thoracic and mediastinal disorders
pleural effusion	2/34 (5.9%)	2	3/36 (8.3%)	3
respiratory difficulty	1/34 (2.9%)	1	1/36 (2.8%)	1

Limitations/Caveats

Multiple surgeons were involved,thus subtle differences in PCNL technique existed between sites. Some surgeons may have defined the stone removal time differently.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.