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The purpose of this study is to assess whether one of two ureteral access sheaths is safer for patients undergoing ureteroscopy. Both sheaths are FDA approved devices and commercially available. The investigators will compare the ability of sheaths to access the kidney through the ureter and will compare damage done to the ureter after completion of the procedure. Access sheaths are standard of care for this procedure; this study seeks to optimize outcomes for patients.
Patients undergoing ureteroscopy who do not have ureteral stents in place and who have not had an ipsilateral procedure within 90 days will be recruited and consented.
The purpose of this study is to compare two ureteral access sheaths in how the sheaths damage the ureter during flexible ureteroscopy.
Condition Intervention Kidney Stones Nephrolithiasis Urolithiasis Device: Cook Flexor or Boston Scientific Navigator HD
Study Type: Interventional Study Design: Intervention Model: Two group randomized assignment Masking: Single blind Primary Purpose: Treatment
Primary Outcome Measures:
• Successful placement of sheath (yes or no).
Secondary Outcome Measures:
Arms Assigned Interventions Device: Cook Flexor and Boston Scientific Navigator HD Device: Cook Flexor or Boston Scientific Navigator HD Patients will be assigned to one of two ureteral access sheaths. If the first sheath is failed to be placed, the backup sheath will be attempted.
Standard ureteroscopy will take place. The intervention takes place before the ureteral access sheath is placed. The patient will be randomized to one of the two sheaths. The randomized 12/14Fr sheath will be attempted. If placed successfully, the rest of the operation continues as planned. If the initial sheath is unable to be placed, a second backup sheath (opposite brand) will be used, also in size 12/14Fr. The surgeon will be asked to rate the ease of placement of the sheath on a standardized scale. If these sheaths fail, it is the surgeon's discretion to continue with the smaller sheath, continue without sheath or place stents and attempt the procedure at a later date. The operation is then continued in standard fashion. Once the ureteroscopy is completed, before the scope and access sheath are removed, video recording of the ureter will be conducted as the ureteroscopy and sheath are removed.
Videos will be analyzed by blinded urologists who will rate the extent of ureteral damage on a standardized scale of 0 to 4 according to the study published by Traxer et al. 2013. Intra-operative data includes total time of initial sheath insertion (in seconds), total time sheath is in place (minutes) from placement to removal, and use of laser. Differences in operative time, ease of placement, ability to maintain access, and ease of instrument passage are also evaluated between devices, as well as success rates, and device failure rates and post-operative complications. Means are compared using a t-test and proportions are compared using a chi-squared test. An intention to treat model is used for statistical analysis. When video ratings differ between surgeons, the higher rating of damage will be used. Inter-rater reliability is assessed with Cohen's kappa coefficient.
After the study, subjects will not be contacted. The investigators will collect data from participants' medical records including information of whether participants develop complications or return for a subsequent procedure as well as size and location of kidney stones prior to the surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cook Flexor | Active Comparator | ureteral access sheath |
|
| Boston Scientific Navigator HD | Active Comparator | ureteral access sheath |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cook Flexor | Device | ureteral access sheath |
| |
| Boston Scientific Navigator |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Successful Sheath Placement | The surgeon documents whether there was Successful placement of sheath (yes or no) | One time point - at the beginning of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Injury to the Ureter | Subjective rating of damage to ureter. At the completion of the procedure, video of the intraluminal ureter is recorded as the sheath is withdrawn. Videos are analyzed by two blinded staff endourologists who score ureteral injury on a standard 5-point scale (0 to 4); reference Traxer and Thomas. | One time point - at the completion of the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Manoj Monga, MD | Urologist | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11176469 | Background | Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93. | |
| 12670551 | Background | Rehman J, Monga M, Landman J, Lee DI, Felfela T, Conradie MC, Srinivas R, Sundaram CP, Clayman RV. Characterization of intrapelvic pressure during ureteropyeloscopy with ureteral access sheaths. Urology. 2003 Apr;61(4):713-8. doi: 10.1016/s0090-4295(02)02440-8. |
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No patients were excluded prior to assignment.
Recruitment was conducted from urology pre-operative clinic from July 1 2014 to May 31 2016
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| ID | Title | Description |
|---|---|---|
| FG000 | Cook Flexor | ureteral access sheath Cook Flexor: ureteral access sheath |
| FG001 | Boston Scientific Navigator HD | ureteral access sheath Boston Scientific Navigator: ureteral access sheath |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cook Flexor | ureteral access sheath Cook Flexor: ureteral access sheath |
| BG001 | Boston Scientific Navigator HD | ureteral access sheath Boston Scientific Navigator: ureteral access sheath |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Successful Sheath Placement | The surgeon documents whether there was Successful placement of sheath (yes or no) | Posted | Count of Participants | Participants | One time point - at the beginning of the procedure |
|
Data was collected intraoperatively (average time one hour)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cook Flexor | ureteral access sheath Cook Flexor: ureteral access sheath | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Manoj Monga MD | Cleveland Clinic | 216-445-8678 | mongam@ccf.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 31, 2014 | Dec 21, 2017 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 31, 2014 | Dec 21, 2017 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D053040 | Nephrolithiasis |
| D052878 | Urolithiasis |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Videos will be analyzed by blinded urologists who will rate the extent of ureteral damage on a standardized scale of 0 to 4 according to the study published by Traxer et al. 2013. After the study, subjects will not be contacted.
| Device |
ureteral access sheath |
|
| Ease of Sheath Placement | Surgeons will be asked to subjectively rate the ease of placement on a standardized scale from 0 to 4, 4 being easiest which will be rated by the surgeon who inserted the sheath immediately after placement. | One time point - at the completion of the procedure |
| 12429296 | Background | Pietrow PK, Auge BK, Delvecchio FC, Silverstein AD, Weizer AZ, Albala DM, Preminger GM. Techniques to maximize flexible ureteroscope longevity. Urology. 2002 Nov;60(5):784-8. doi: 10.1016/s0090-4295(02)01948-9. |
| 15006050 | Background | Auge BK, Pietrow PK, Lallas CD, Raj GV, Santa-Cruz RW, Preminger GM. Ureteral access sheath provides protection against elevated renal pressures during routine flexible ureteroscopic stone manipulation. J Endourol. 2004 Feb;18(1):33-6. doi: 10.1089/089277904322836631. |
| 12470467 | Background | Lallas CD, Auge BK, Raj GV, Santa-Cruz R, Madden JF, Preminger GM. Laser Doppler flowmetric determination of ureteral blood flow after ureteral access sheath placement. J Endourol. 2002 Oct;16(8):583-90. doi: 10.1089/089277902320913288. |
| 22982421 | Background | Traxer O, Thomas A. Prospective evaluation and classification of ureteral wall injuries resulting from insertion of a ureteral access sheath during retrograde intrarenal surgery. J Urol. 2013 Feb;189(2):580-4. doi: 10.1016/j.juro.2012.08.197. Epub 2012 Oct 8. |
| 22698147 | Background | Schoenthaler M, Wilhelm K, Kuehhas FE, Farin E, Bach C, Buchholz N, Miernik A. Postureteroscopic lesion scale: a new management modified organ injury scale--evaluation in 435 ureteroscopic patients. J Endourol. 2012 Nov;26(11):1425-30. doi: 10.1089/end.2012.0227. Epub 2012 Aug 27. |
| 12639636 | Background | Delvecchio FC, Auge BK, Brizuela RM, Weizer AZ, Silverstein AD, Lallas CD, Pietrow PK, Albala DM, Preminger GM. Assessment of stricture formation with the ureteral access sheath. Urology. 2003 Mar;61(3):518-22; discussion 522. doi: 10.1016/s0090-4295(02)02433-0. |
| 21706214 | Background | Ayyathurai R, Kanagarajah P, Shields J, Young E, Alvarez A, Bird VG. Single-center clinical comparison of two reinforced ureteral access sheaths for retrograde ureteroscopic treatment of urinary lithiasis. Int Urol Nephrol. 2012 Apr;44(2):409-14. doi: 10.1007/s11255-011-0017-8. Epub 2011 Jun 25. |
| 25661780 | Background | De S, Sarkissian C, Torricelli FC, Brown R, Monga M. New ureteral access sheaths: a double standard. Urology. 2015 Apr;85(4):757-63. doi: 10.1016/j.urology.2014.07.009. Epub 2015 Feb 4. |
| 25244070 | Background | Mogilevkin Y, Sofer M, Margel D, Greenstein A, Lifshitz D. Predicting an effective ureteral access sheath insertion: a bicenter prospective study. J Endourol. 2014 Dec;28(12):1414-7. doi: 10.1089/end.2014.0215. |
| 18632141 | Background | Fuganti PE, Pires S, Branco R, Porto J. Predictive factors for intraoperative complications in semirigid ureteroscopy: analysis of 1235 ballistic ureterolithotripsies. Urology. 2008 Oct;72(4):770-4. doi: 10.1016/j.urology.2008.05.042. Epub 2008 Jul 16. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Number of Participants With Injury to the Ureter | Subjective rating of damage to ureter. At the completion of the procedure, video of the intraluminal ureter is recorded as the sheath is withdrawn. Videos are analyzed by two blinded staff endourologists who score ureteral injury on a standard 5-point scale (0 to 4); reference Traxer and Thomas. | Patients undergoing procedures with each device. | Posted | Count of Participants | Participants | One time point - at the completion of the procedure |
|
|
|
| Secondary | Ease of Sheath Placement | Surgeons will be asked to subjectively rate the ease of placement on a standardized scale from 0 to 4, 4 being easiest which will be rated by the surgeon who inserted the sheath immediately after placement. | patients undergoing ureteroscopy with each device. | Posted | Number | units on a scale | One time point - at the completion of the procedure |
|
|
|
| 44 |
| 0 |
| 44 |
| 0 |
| 44 |
| EG001 | Boston Scientific Navigator HD | ureteral access sheath Boston Scientific Navigator: ureteral access sheath | 0 | 43 | 0 | 43 | 0 | 43 |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |