Effectiveness and Safety of LED Light Source System for Endoscope (NCT04561583) | Clinical Trial Compass
WithdrawnNot Applicable
Effectiveness and Safety of LED Light Source System for Endoscope
Stopped: The study was registered but never started.
China0Started 2020-09
Plain-language summary
This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 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 inclusion and exclusion criteria are verified; after that, 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; 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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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subjects who should receive laparoscopic cholecystectomy on a selected day Symptoms of such subjects include gallstone, cholecystitis, or gallbladder polyp≥0.8 cm
✓. Aged between 18 and 75
✓. All subjects voluntarily participate in the clinical trial and are asked to sign the informed consent form
Exclusion criteria
✕. Subjects suffering acute cholecystitis and cholangitis
✕. Subjects requiring laparotomy
✕. Women during pregnancy or lactation
✕. Subjects expected to give birth to a child within 3 months after the trial
✕. Subjects suffering liver cirrhosis
✕. Subjects allergic to ICG or iodine
✕. Subjects with cardiopulmonary insufficiency and those intolerant of surgery
. Subjects with abnormal renal and liver function: ①Aspartate aminotransferase AST or alanine aminotransferase ALT exceeding 3 times of the upper limit of the normal range; ② Serum creatinine \> 2.0 mg/dL or ≥ 176.8 μmol/L