Impact Ureteral Sheath Design During Ureteroscopy

December 21, 2017 updated by: Manoj Monga, MD, The Cleveland Clinic

The Impact of Ureteral Access Sheath Design on Ease of Placement and Ureteral Wall Injury During Flexible Ureteroscopy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 At the completion of the procedure, video of the intraluminal ureter is recorded as the sheath is withdrawn.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 Type

Interventional

Enrollment (Actual)

95

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Injury to the Ureter
Time Frame: 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.
One time point - at the completion of the procedure
Ease of Sheath Placement
Time Frame: 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.
One time point - at the completion of the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Manoj Monga, MD, Urologist

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 27, 2014

Primary Completion (Actual)

July 1, 2016

Study Completion (Actual)

July 1, 2016

Study Registration Dates

First Submitted

November 13, 2017

First Submitted That Met QC Criteria

November 20, 2017

First Posted (Actual)

November 21, 2017

Study Record Updates

Last Update Posted (Actual)

January 23, 2018

Last Update Submitted That Met QC Criteria

December 21, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-632

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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