Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of… (NCT06722664) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Efficacy and Safety of OsrhCT and Dimethicone Emulsion Before Upper Endoscopy on Visualization of the Gastric Mucosa.
China336 participantsStarted 2024-12-19
Plain-language summary
Study was designed to evaluate efficacy of OsrhCT and Dimethicone emulsion before upper endoscopy on visibility of gastric mucosa.
A total of 336 subjects (both male and female) are expected to be enrolled in this trial.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Patients indicated for gastroscopy examination;
✓. Subjects fully understand the content, process, and possible adverse reactions of the trial and voluntary participation with signed informed consent;
✓. Able to complete the research according to the requirements of the experimental plan;
✓. Subjects (including their spouses) voluntarily have no pregnancy plans and use contraception during the study and within 3 months after the last administration of the study drug;
✓. Aged 18-75 years (inclusive), male or female;
Exclusion criteria
✕. Known allergy to chymotrypsin; Known to be allergic to preparation or anesthesia medication before gastroscopy examination;
✕. Patients plan to undergo gastroscopic treatment, such as endoscopic titanium clip for hemostasis, esophagogastric fundal variceal ligation, endoscopic mucosal stripping, etc;
✕. Subjects accessed not to stand sedation anesthesia or gastroscopy examination;
✕. Severe cardiovascular, pulmonary, or cerebral diseases, such as angina, heart failure, and new-onset stroke; or severe liver disease, cirrhosis, or esophagogastric fundus varices;
✕. Suspected or known esophageal fistula, tracheal fistula, intestinal obstruction, active gastrointestinal bleeding, gastric perforation, history of anatomically altered upper GI surgery;
✕
What they're measuring
1
Total visibility score (TVS) evaluated by blinded endoscopists
Timeframe: Through study completion, an average of 3 months