Not provided
Not provided
Not provided
Not provided
Not provided
contract never completed
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to determine the efficacy of RetroPerc® in obtaining renal access for percutaneous nephrolithotomy
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (retrograde nephrostomy) | Experimental |
| |
| Control Group ( antegrade nephrostomy) | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| retrograde nephrostomy | Device | this will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment efficacy as measured by the time taken from diagnosis to nephrostomy access | end of procedure (about 4-8 weeks from diagnosis) | |
| Treatment efficacy as measured by total time of access operation. | end of procedure( about 90 minutes after start of procedure) | |
| Treatment efficacy as measured by total time of access operation fluoroscopy | end of procedure( about 90 minutes after start of procedure) | |
| Treatment efficacy as measured by total time of lithotomy operation | end of procedure(about 3 hours after start of procedure) | |
| Treatment efficacy as measured by total time of lithotomy operation fluoroscopy | (end of procedure)about 3 hours after start of procedure | |
| Treatment efficacy as measured by length of post-operative hospital stay | 24 hours after procedure | |
| Number of patients that are stone free | stone free is defined as <2mm on non-contrast computed tomography | 6-12 weeks after procedure |
| Number of patients with symptom free survival as defined as lack of flank pain | 6-12 weeks after procedure | |
| Number of patients with symptom free survival as defined as lack of presence of urinary or gastrointestinal symptoms, |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with nephrostomy access adequate for stone treatment | end of procedure( abut 3 hours from start of procedure) | |
| Number of patients with normal vital signs | end of procedure( abut 3 hours from start of procedure) |
Not provided
Inclusion Criteria:
-Renal pelvis and proximal ureteral stones >10 mm confirmed with non-contrast computed tomography
Exclusion Criteria:
Suspected pyelonephritis.
Prior percutaneous nephrolithotomy procedure in affected kidney.
Mid-ureteral or distal ureteral stones.
Pregnancy.
Anatomical abnormal kidney, including:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nadeem N Dhanani, MD,MPH | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Texas Health Science Center at Houston | Houston | Texas | 77030 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| antegrade nephrostomy | Device | this will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months |
|
| 6-12 weeks after procedure |
| Number of patients with symptom free survival as defined as lack of limitations to work | 6-12 weeks after procedure |
| Number of patients with symptom free survival as defined as lack of limitations to social or daily activities. | 6-12 weeks after procedure |
| Number of patients with normal laboratory values | laboratory values include complete metabolic panel and urinalysis | 24 hours after procedure |
| Number of patients with an infection rate which is defined as a positive culture within the study time period | 6-12 weeks after procedure |
| Number of patients that require pain medication (defined as discharge with an opioid prescription). | 6-12 weeks after procedure |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052878 | Urolithiasis |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |