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Impact Ureteral Sheath Design During Ureteroscopy

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ClinicalTrials.gov Identifier: NCT03349099
Recruitment Status : Completed
First Posted : November 21, 2017
Results First Posted : January 23, 2018
Last Update Posted : January 23, 2018
Sponsor:
Information provided by (Responsible Party):
Manoj Monga, MD, The Cleveland Clinic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Care Provider);   Primary Purpose: Treatment
Conditions Renal Stone
Nephrolithiasis
Urolithiasis
Interventions Device: Cook Flexor
Device: Boston Scientific Navigator
Enrollment 95
Recruitment Details Recruitment was conducted from urology pre-operative clinic from July 1 2014 to May 31 2016
Pre-assignment Details No patients were excluded prior to assignment.
Arm/Group Title Cook Flexor Boston Scientific Navigator HD
Hide 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
Reason Not Completed
Physician Decision             3             4
Stone migrated from the kidney             1             0
Arm/Group Title Cook Flexor Boston Scientific Navigator HD Total
Hide 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 Number of Baseline Participants 48 47 95
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 48 participants 47 participants 95 participants
53.1  (9) 50.4  (11) 52.1  (10)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 48 participants 47 participants 95 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   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 48 participants 47 participants 95 participants
48 47 95
1.Primary Outcome
Title Number of Participants With Successful Sheath Placement
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cook Flexor Boston Scientific Navigator HD
Hide Arm/Group Description:

ureteral access sheath

Cook Flexor: ureteral access sheath

ureteral access sheath

Boston Scientific Navigator: ureteral access sheath

Overall Number of Participants Analyzed 44 43
Measure Type: Count of Participants
Unit of Measure: Participants
37
  84.1%
39
  90.7%
2.Secondary Outcome
Title Number of Participants With Injury to the Ureter
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Patients undergoing procedures with each device.
Arm/Group Title Cook Flexor Boston Scientific Navigator HD
Hide Arm/Group Description:

ureteral access sheath

Cook Flexor: ureteral access sheath

ureteral access sheath

Boston Scientific Navigator: ureteral access sheath

Overall Number of Participants Analyzed 44 43
Measure Type: Count of Participants
Unit of Measure: Participants
36
  81.8%
27
  62.8%
3.Secondary Outcome
Title Ease of Sheath Placement
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
patients undergoing ureteroscopy with each device.
Arm/Group Title Cook Flexor Boston Scientific Navigator HD
Hide Arm/Group Description:

ureteral access sheath

Cook Flexor: ureteral access sheath

ureteral access sheath

Boston Scientific Navigator: ureteral access sheath

Overall Number of Participants Analyzed 44 43
Measure Type: Number
Unit of Measure: units on a scale
2.9 3.4
Time Frame Data was collected intraoperatively (average time one hour)
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cook Flexor Boston Scientific Navigator HD
Hide 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 (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/43 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Cook Flexor Boston Scientific Navigator HD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/43 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Cook Flexor Boston Scientific Navigator HD
Affected / at Risk (%) Affected / at Risk (%)
Total   0/44 (0.00%)   0/43 (0.00%) 
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.
Results Point of Contact
Name/Title: Manoj Monga MD
Organization: Cleveland Clinic
Phone: 216-445-8678
Publications:
Responsible Party: Manoj Monga, MD, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT03349099     History of Changes
Other Study ID Numbers: 14-632
First Submitted: November 13, 2017
First Posted: November 21, 2017
Results First Submitted: November 29, 2017
Results First Posted: January 23, 2018
Last Update Posted: January 23, 2018