Impact Ureteral Sheath Design During Ureteroscopy

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT03349099
• Collaborator: (none)
• Enrollment: 95
• Arms: 2
• Actual Duration (Months): 24.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Stone; Nephrolithiasis; Urolithiasis	Device: Cook Flexor; Device: Boston Scientific Navigator	N/A

Detailed Description

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:

• 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 At the completion of the procedure, video of the intraluminal ureter is recorded as the sheath is withdrawn.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 to score ureteral injury on a standard 5-point scale (0 to 4); reference Traxer and Thomas.

• Ease of placement of each sheath. 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.

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 95 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Care Provider)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: The Impact of Ureteral Access Sheath Design on Ease of Placement and Ureteral Wall Injury During Flexible Ureteroscopy
• Actual Study Start Date: Jun 27, 2014
• Actual Primary Completion Date: Jul 1, 2016
• Actual Study Completion Date: Jul 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cook Flexor ureteral access sheath	Device: Cook Flexor; ureteral access sheath
Active Comparator: Boston Scientific Navigator HD ureteral access sheath	Device: Boston Scientific Navigator; ureteral access sheath

Outcome Measures

Primary Outcome Measures

1. Number of Participants With Successful Sheath Placement [One time point - at the beginning of the procedure]

   The surgeon documents whether there was Successful placement of sheath (yes or no)

Secondary Outcome Measures

1. Number of Participants With Injury to the Ureter [One time point - at the completion of the procedure]

   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.

2. Ease of Sheath Placement [One time point - at the completion of the procedure]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Patients planned for ureteroscopy

• Current CT scan within 90-days before the operation

• Able to give informed consent

• Ages 18 years and older

Exclusion Criteria:

• Inability to give informed consent

• Age less than 18 years

• Pregnant

• Stones in the ureter

• Having previous ipsilateral ureteral or renal surgery within 90 days

• Having stents placed in ipsilateral ureter within 90 days

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Manoj Monga, MD, Urologist

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - May 31, 2014
• Informed Consent Form - May 31, 2014

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• Kourambas J, Byrne RR, Preminger GM. Does a ureteral access sheath facilitate ureteroscopy? J Urol. 2001 Mar;165(3):789-93.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Manoj Monga, MD, Director of Endourology and Stone Disease, The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT03349099
• Other Study ID Numbers: 14-632
• First Posted: Nov 21, 2017
• Last Update Posted: Jan 23, 2018
• Last Verified: Dec 1, 2017

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Urolithiasis; Nephrolithiasis; Kidney Calculi

Study Results

Participant Flow

Recruitment Details	Recruitment was conducted from urology pre-operative clinic from July 1 2014 to May 31 2016
Pre-assignment Detail	No patients were excluded prior to assignment.

Arm/Group Title	Cook Flexor	Boston Scientific Navigator HD
Arm/Group Description	ureteral access sheath Cook Flexor: ureteral access sheath	ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Period Title: Overall Study
STARTED	48	47
COMPLETED	44	43
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Cook Flexor	Boston Scientific Navigator HD	Total
Arm/Group Description	ureteral access sheath Cook Flexor: ureteral access sheath	ureteral access sheath Boston Scientific Navigator: ureteral access sheath	Total of all reporting groups
Overall Participants	48	47	95
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	53.1 (9)	50.4 (11)	52.1 (10)
Sex: Female, Male (Count of Participants)
Female	28 58.3%	24 51.1%	52 54.7%
Male	20 41.7%	23 48.9%	43 45.3%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	48 100%	47 100%	95 100%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Successful Sheath Placement
Description	The surgeon documents whether there was Successful placement of sheath (yes or no)
Time Frame	One time point - at the beginning of the procedure

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cook Flexor	Boston Scientific Navigator HD
Arm/Group Description	ureteral access sheath Cook Flexor: ureteral access sheath	ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Measure Participants	44	43
Count of Participants [Participants]	37 77.1%	39 83%

2. Secondary Outcome

Title	Number of Participants With Injury to the Ureter
Description	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.
Time Frame	One time point - at the completion of the procedure

Outcome Measure Data

Analysis Population Description

Patients undergoing procedures with each device.

Arm/Group Title	Cook Flexor	Boston Scientific Navigator HD
Arm/Group Description	ureteral access sheath Cook Flexor: ureteral access sheath	ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Measure Participants	44	43
Count of Participants [Participants]	36 75%	27 57.4%

3. Secondary Outcome

Title	Ease of Sheath Placement
Description	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.
Time Frame	One time point - at the completion of the procedure

Outcome Measure Data

Analysis Population Description

patients undergoing ureteroscopy with each device.

Arm/Group Title	Cook Flexor	Boston Scientific Navigator HD
Arm/Group Description	ureteral access sheath Cook Flexor: ureteral access sheath	ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Measure Participants	44	43
Number [units on a scale]	2.9	3.4

Adverse Events

Time Frame	Data was collected intraoperatively (average time one hour)
Arm/Group Title	Cook Flexor		Boston Scientific Navigator HD
Arm/Group Description	ureteral access sheath Cook Flexor: ureteral access sheath		ureteral access sheath Boston Scientific Navigator: ureteral access sheath
All Cause Mortality
	Cook Flexor		Boston Scientific Navigator HD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/43 (0%)
Serious Adverse Events
	Cook Flexor		Boston Scientific Navigator HD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/43 (0%)
Other (Not Including Serious) Adverse Events
	Cook Flexor		Boston Scientific Navigator HD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/44 (0%)		0/43 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.