Trial Outcomes & Findings for Trial Comparing Dual Probe Ultrasonic Lithotripsy to a Single Probe Ultrasonic Lithotripsy (NCT NCT00351351)

NCT ID: NCT00351351

Last Updated: 2017-03-30

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 70 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2017-03-30

Participant Flow

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

Participant milestones

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

Reasons for withdrawal

Measure	Cyberwand Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite	Currently Available Lithotripsy Technology Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic
Overall Study surgical access pbs; device issues	9	4

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Cyberwand n=34 Participants Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite	Currently Available Lithotripsy Techology n=36 Participants Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic	Total n=70 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants	31 Participants n=7 Participants	59 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants	14 Participants n=7 Participants	28 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Region of Enrollment United States	24 participants n=5 Participants	26 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment Canada	10 participants n=5 Participants	10 participants n=7 Participants	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 months

Population: 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

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

Outcome measures

Measure	Cyberwand n=25 Participants Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite	Currently Available Lithotripsy Techology n=32 Participants Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic
Kidney Stone Clearance Rate	61.9 mm^2/min Interval 6.1 to 222.69	75.8 mm^2/min Interval 9.16 to 551.9

Adverse Events

Cyberwand

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

Currently Available Lithotripsy Technology

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cyberwand n=34 participants at risk Cyberwand Cyberwand : FDA approved - dual probe intracorporeal lithotrite	Currently Available Lithotripsy Technology n=36 participants at risk Currently available lithotripsy technology single probe ultrasonic : FDA-approved - single probe ultrasonic
Infections and infestations fever	0.00% 0/34	8.3% 3/36 • Number of events 3
Renal and urinary disorders hydronephrosis	0.00% 0/34	2.8% 1/36 • Number of events 1
Gastrointestinal disorders ileus	2.9% 1/34 • Number of events 1	0.00% 0/36
Renal and urinary disorders perinephric haematoma	2.9% 1/34 • Number of events 1	0.00% 0/36
General disorders persistent flank pain	2.9% 1/34 • Number of events 1	0.00% 0/36
Respiratory, thoracic and mediastinal disorders pleural effusion	5.9% 2/34 • Number of events 2	8.3% 3/36 • Number of events 3
Respiratory, thoracic and mediastinal disorders respiratory difficulty	2.9% 1/34 • Number of events 1	2.8% 1/36 • Number of events 1
Renal and urinary disorders discharged home with nephrostomy tube	11.8% 4/34 • Number of events 4	19.4% 7/36 • Number of events 7

Additional Information

James Lingeman, MD

IU Health Methodist Hospital

Phone: 317-962-0870

Email: lrawlings@iuhealth.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place