Trial Outcomes & Findings for Impact Ureteral Sheath Design During Ureteroscopy (NCT NCT03349099)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

95 participants

Primary outcome timeframe

One time point - at the beginning of the procedure

Results posted on

2018-01-23

Participant Flow

Recruitment was conducted from urology pre-operative clinic from July 1 2014 to May 31 2016

No patients were excluded prior to assignment.

Participant milestones

Participant milestones
Measure	Cook Flexor ureteral access sheath Cook Flexor: ureteral access sheath	Boston Scientific Navigator HD ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Overall Study STARTED	48	47
Overall Study COMPLETED	44	43
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Cook Flexor ureteral access sheath Cook Flexor: ureteral access sheath	Boston Scientific Navigator HD ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Overall Study Physician Decision	3	4
Overall Study Stone migrated from the kidney	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cook Flexor n=48 Participants ureteral access sheath Cook Flexor: ureteral access sheath	Boston Scientific Navigator HD n=47 Participants ureteral access sheath Boston Scientific Navigator: ureteral access sheath	Total n=95 Participants Total of all reporting groups
Age, Continuous	53.1 years STANDARD_DEVIATION 9 • n=48 Participants	50.4 years STANDARD_DEVIATION 11 • n=47 Participants	52.1 years STANDARD_DEVIATION 10 • n=95 Participants
Sex: Female, Male Female	28 Participants n=48 Participants	24 Participants n=47 Participants	52 Participants n=95 Participants
Sex: Female, Male Male	20 Participants n=48 Participants	23 Participants n=47 Participants	43 Participants n=95 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	48 participants n=48 Participants	47 participants n=47 Participants	95 participants n=95 Participants

PRIMARY outcome

Timeframe: One time point - at the beginning of the procedure

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

Outcome measures

Outcome measures
Measure	Cook Flexor n=44 Participants ureteral access sheath Cook Flexor: ureteral access sheath	Boston Scientific Navigator HD n=43 Participants ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Number of Participants With Successful Sheath Placement	37 Participants	39 Participants

SECONDARY outcome

Timeframe: One time point - at the completion of the procedure

Population: Patients undergoing procedures with each device.

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.

Outcome measures

Outcome measures
Measure	Cook Flexor n=44 Participants ureteral access sheath Cook Flexor: ureteral access sheath	Boston Scientific Navigator HD n=43 Participants ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Number of Participants With Injury to the Ureter	36 Participants	27 Participants

SECONDARY outcome

Timeframe: One time point - at the completion of the procedure

Population: patients undergoing ureteroscopy with each device.

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.

Outcome measures

Outcome measures
Measure	Cook Flexor n=44 Participants ureteral access sheath Cook Flexor: ureteral access sheath	Boston Scientific Navigator HD n=43 Participants ureteral access sheath Boston Scientific Navigator: ureteral access sheath
Ease of Sheath Placement	2.9 units on a scale	3.4 units on a scale

Adverse Events

Cook Flexor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Boston Scientific Navigator HD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Manoj Monga MD

Cleveland Clinic

Phone: 216-445-8678

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place