NCT03349099

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
95

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 13, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 21, 2017

Completed
2 months until next milestone

Results Posted

Study results publicly available

January 23, 2018

Completed
Last Updated

January 23, 2018

Status Verified

December 1, 2017

Enrollment Period

2 years

First QC Date

November 13, 2017

Results QC Date

November 29, 2017

Last Update Submit

December 21, 2017

Conditions

Renal StoneNephrolithiasisUrolithiasis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Number of Participants With Injury to the Ureter

    One time point - at the completion of the procedure

  • Ease of Sheath Placement

    One time point - at the completion of the procedure

Study Arms (2)

Cook Flexor

ACTIVE COMPARATOR

ureteral access sheath

Device: Cook Flexor

Boston Scientific Navigator HD

ACTIVE COMPARATOR

ureteral access sheath

Device: Boston Scientific Navigator

Interventions

Cook FlexorDEVICE

ureteral access sheath

Cook Flexor
Boston Scientific NavigatorDEVICE

ureteral access sheath

Boston Scientific Navigator HD

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients planned for ureteroscopy
  • Current CT scan within 90-days before the operation
  • Able to give informed consent
  • Ages 18 years and older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

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

    PMID: 11176469BACKGROUND

  • 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.

    PMID: 12670551BACKGROUND

  • 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.

    PMID: 12429296BACKGROUND

  • 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.

    PMID: 15006050BACKGROUND

  • 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.

    PMID: 12470467BACKGROUND

  • 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.

    PMID: 22982421BACKGROUND

  • 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.

    PMID: 22698147BACKGROUND

  • 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.

    PMID: 12639636BACKGROUND

  • 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.

    PMID: 21706214BACKGROUND

  • 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.

    PMID: 25661780BACKGROUND

  • 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.

    PMID: 25244070BACKGROUND

  • 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.

    PMID: 18632141BACKGROUND

MeSH Terms

Conditions

NephrolithiasisUrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Results Point of Contact

Title
Manoj Monga MD
Organization
Cleveland Clinic
mongam@ccf.org
216-445-8678

Study Officials

  • Manoj Monga, MD

    Urologist

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Endourology and Stone Disease

Study Record Dates

First Submitted

November 13, 2017

First Posted

November 21, 2017

Study Start

June 27, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

January 23, 2018

Results First Posted

January 23, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share