Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| KARL STORZ Endoscopy-America, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
The objective of the study is to compare the stone free rates with ureteroscopy utilizing the ClearPETRA suction ureteral access sheath, and mini-PCNL; both procedures and ClearPETRA sheaths are standard of care and are used regularly for stone treatment. Our primary objective is to assess the complete stone free rate with both procedures.
With the advent of mini-PCNLs, some endourologists have been utilizing the technique to treat renal calculi up to 3cm in size with better stone free rates and similar comorbidity compared to ureteroscopy. These procedures require percutaneous renal access, and it is associated with greater length of stay and fluoroscopy time.
The ClearPETRA ureteral access sheath has shown great promise with improving stone free rates, decreasing intra-renal pressure and delivering some of the benefits of mini-PCNL without the added risk associated with obtaining percutaneous renal access.
The ClearPETRA flexible suction ureteral access sheath anecdotally improves efficiency and allows endourologists to better clear stone debris when compared to traditional ureteral access sheaths. We have yet to see a comparison between suction ureteral access sheaths and mini-PCNL with the suction renal access sheath.
Study Hypothesis: Compared to traditional access sheaths, using ClearPETRA access sheaths will result in an improvement in stone free rates with both modalities, with lower complications. Using ClearPETRA access sheaths in both modalities compared to traditional access sheaths should result in less of a difference in stone free rates between the ureteroscopy group and the mini-PCNL group.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ureteroscopy | Active Comparator | Patients randomized to this arm will have their stones treated using the method of Ureteroscopy in a standardized fashion. A second 0.035in sensor guidewire will then be advanced up to the renal pelvis with placement confirmed by fluoroscopy. Placement of a 12/14Fr ClearPETRA ureteral access sheath will be attempted. If this is unsuccessful, a 11/13Fr ClearPETRA ureteral access sheath will be advanced over the wire. If this is unsuccessful, a 5Fr open ended ureteral catheter will be placed and procedure will be converted to a miniPCNL. Lithotripsy will be performed with the MOSES 2.0 high power Holmium laser with settings of 0.3J and 120Hz or 2J and 20Hz depending on stone location and appearance. Stones will be extracted with the suction access sheath. A ureteral stent will be placed at the conclusion of the procedure. |
|
| Mini-PCNL | Active Comparator | Will be performed by first starting with supine flexible cystoscopy to cannulate the ureteral orifice with a 5Fr open ended ureteral catheter. The patient will then be repositioned prone with 1-2 bumps placed transversely across the chest. Contrast will be instilled into the ureteral catheter and renal access will be obtained fluoroscopically with the triangulation technique. Once access is obtained, the tract will be dilated to 20Fr and a 18/20Fr ClearPETRA renal access sheath will be inserted to assess the collecting system. If there is concern that the 20Fr access is not sufficient to clear the stone, the tract will be upsized to 24 or 30Fr. The stones will be evacuated with the Trilogy Lithotripter and/or laser, suction and/or basket extraction. A ureteral stent will be placed at the conclusion of the procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearPETRA suction access sheath | Device | Ureteroscopy utilizing the ClearPETRA suction access sheath. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Stone free rate | Stone free rate (no residual stone) on post-procedure CT | 4 weeks post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Surgery time | Surgery time (minutes) | Procedure day (1 day) |
| Complication rate | Complication rate (Clavien-Dindo) (%) | Procedure day (1 day) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant individuals
Those with anomalous renal anatomy
Patients with a urinary diversion (ex: Ileal conduit, reservoir, bladder substitute, etc.)
Any condition rendering patient medically unfit to undergo either procedure (Bleeding diasthesis)
Patients who lack decisional capacity
Patients who are non-english speakers*
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alyssa McDonald, MPH | Contact | 312-695-8146 | alyssa.mcdonald@northwestern.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
Not provided
| ID | Term |
|---|---|
| D007669 | Kidney Calculi |
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ClearPETRA suction access sheath | Device | Mini-PCNL utilizing the ClearPETRA suction access sheath |
|
| Unplanned hospital visits | Unplanned hospital visits (ED/clinic) | 90 days postoperatively |
| Need for additional procedure | Need for additional procedure (within 90 days postoperatively) | 90 days postoperatively |
| Length of stay | Length of stay hospital stay (if admitted post-procedure, or readmitted) | Perioperatively (starting at Baseline/Procedure Date) |
| Inability to access ureter | Intra-operative complications including inability to access the ureter ureteroscopically or need to upsize the renal access sheath with the percutaneous approach. | Procedure day (1 day) |
| Need to upsize from 18Fr Sheath | Need to upsize from 18Fr (PCNL group) | Procedure day (1 day) |
| Occurrence of post-procedure sepsis | Post-op sepsis | Perioperatively (starting at Baseline/Procedure Date) |
| Hospital / patient costs (in total for procedure and any necessary postoperative hospital admissions or procedures related to the initial procedure). | Perioperatively (starting at Baseline/Procedure Date) |
| D000091642 | Urogenital Diseases |
| D014545 | Urinary Calculi |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |