Clinical Trial Details
— Status: Withdrawn
Administrative data
NCT number |
NCT04561414 |
Other study ID # |
Stryker03 |
Secondary ID |
|
Status |
Withdrawn |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
May 2021 |
Est. completion date |
May 2022 |
Study information
Verified date |
April 2021 |
Source |
Stryker Orthopaedics |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
This clinical trial is a prospective, multi-center, single-blind, parallel, randomized
controlled superiority clinical trial. The trial will be carried out in 5 centers, involving
120 subjects as estimated who will be divided into the test group or control group randomly
on an equal basis (each group includes 60 subjects).
This trial will be carried out in 4 stages, including the screening period, random grouping,
operation date and follow-up period. In the screening period, the informed consent forms are
collected and candidates are screened; after screening, the accepted subjects will be
randomly divided into the control group or test group; on the operation date, the operation
is carried out using the device tested; safety follow-up visit is carried out during the
follow-up period.
Description:
The prospective, multi-center, single-blind, parallel, randomized controlled superiority
trial design is adopted to evaluate the safety and effectiveness of the LED light source
system for endoscope during ureter transillumination. The trial will be carried out in 5
centers, with the competitive grouping mode adopted. This trial will be carried out in the
General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal
cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation
(60 subjects for each of the test group and control group) are involved. The subjects, after
signing the informed consent form approved by the Ethics Committee, will be screened by the
investigators. Qualified subjects who meet all the inclusion criteria and do not meet any of
the exclusion criteria will be randomly divided into the control group or the test group. The
subjects in the control group will accept the ureteral stent (manufacturer: Cook Ireland
Ltd.) during operation. The subjects in the test group will undergo surgery using the LED
light source system for endoscope and the supporting IRIS ureter kit. On the operation date,
the investigators will score the performance using a scale to evaluate the resolution of the
ureter in the whole process of operation. During the follow-up period, the investigators will
evaluate the safety of the device based on the results of vital signs, physical examination,
blood routine examination, routine urine examination, blood biochemistry, 12-lead ECG and
B-mode ultrasonography of urinary system.