WithdrawnNot Applicable

Objective to Evaluate the Safety and Effectiveness of LED Light Source System for Endoscopy in Ureteral Radiography

Stopped: Study was registered but never started.

China0Started 2021-05

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. The surgeon believes preventative placement of a ureteral stent is necessary and the target organ to be excised in the surgery is closely related to the ureter (e.g. representative specialized operations such as rectal cancer and endometriosis, cervical cancer, adenomyosis and pelvic adhesion).
✓. Age: 18 to 80 years old;
✓. All subjects voluntarily participate in the clinical trial and are asked to sign the informed consent form.

Exclusion criteria

✕. Women during pregnancy or lactation;
✕. Subjects are involved in other clinical trials at the same time; Hydronephrosis due to urinary tract obstruction; Laparotomy is expected (except for conversion to laparotomy during operation);
✕. Other conditions deemed by the investigators as unsuitable for operation;
✕. Other conditions deemed by the investigators as unsuitable for the trial (including anticipated catheterizing failure).

What they're measuring

Resolution of the ureter in the whole operation.

Timeframe: in the whole process of operation

Trial details

NCT IDNCT04561414

SponsorStryker Orthopaedics

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-05

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