RETRO Study (RETrograde Renal Access Outcomes)
ConditionRenal Stones
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Kansas Medical Center
About this trial
The goal of this observational study is to learn about the benefit of using RetroPerc® in obtaining renal access for percutaneous nephrolithotomy. The device is already used in routine clinical practice by urologists around the country.
Participants who are already scheduled to undergo percutaneous nephrolithotomy as part of their regular care will be asked to participate.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Renal stone or total linear sum of 1.5-3cm cm in maximum dimension (largest diameter in axial or coronal)--- multiple stones should be summed to determine stone size.
Age >=18 years of age
Gender: both men and women included.
Ethnic background: all ethnicities will be included in the study population and the specific ethnic diversity present in the study population will reflect the geographic distributions of the participating institutions.
Disqualifiers
Active pregnancy
BMI >45
Severe Hydronephrosis - renal pelvis diameter > 20mm
Flank window < 4 cm are ineligible for puncture
Trial population
Participants undergoing percutaneous nephrolithotomy for treatment of their renal stone (s) total linear sum of 1.5 to 3cm cm in maximum dimension.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
RetroPerc®
DeviceThe RetroPerc® will be used to obtain renal access.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Percutaneous Nephrolithotomy1 intervention
Trial outcomes
Primary outcomes
1
Proportion of successful renal access per access attempts
The proportion of successful renal access was compared to the renal access attempts (e.g. 100 success attempts/110 attempts).
Time frame
ProcedureSecondary outcomes
1
Location of Renal Access
The location of renal access was determined during the procedure. Location of access was defined as upper pole, mid pole, and lower pole.
Time frame
Procedure2
Time to gain renal access
The time to gain renal access was defined as the time the ureteroscope enters the kidney to the time when the nephroscope enters the kidney
Time frame
Procedure3
Total Procedure Time
The total procedure time is defined as the time when the cyso/urethroscope enters the urethra to the time time of skin closure.
Time frame
Procedure4
Length of Post-Operative Hospital Stay
The post-operative hospital length of stay range is defined from 0 days to longer than 5 days.
Time frame
Day 0 to 3 Months Post-OperativeSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Kansas Medical Center
Lead sponsor
RetroPerc Inc
Collaborator
Source ClinicalTrials.gov