None listed
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1) Male or female subjects aged 76 to 85 years at the time of informed consent 2) Subjects scheduled to undergo colonoscopy for diagnostic, screening, or follow-up purposes 3) Subjects who voluntarily decide to participate in this clinical study and provide written informed consent
Exclusion criteria
Exclusion criteria: 1) Patients who have undergone gastrointestinal resection such as bowel resection or gastrectomy, or those with acute abdominal conditions requiring surgery (e.g., acute appendicitis, toxic colitis, or toxic megacolon) 2) Subjects with known or suspected intestinal obstruction, gastrointestinal obstruction, gastrointestinal ulcer, gastroparesis, or inflammatory bowel disease 3) Patients with gastrointestinal ulcer, gastroparesis, or gastric stasis 4) Subjects with severe renal impairment (glomerular filtration rate <30 mL/min/1.73 m²), congestive heart failure, heart disease (e.g., ischemic heart disease or coronary artery disease within the past 6 months), liver cirrhosis, ascites, or other serious underlying medical conditions 5) Subjects with known hypersensitivity to the investigational bowel preparation or any of its components 6) Subjects with a history of glucose-6-phosphate dehydrogenase (G6PD) deficiency 7) Subjects with active cancer 8) Subjects with severe constipation or those who have taken laxatives or gastrointestinal motility agents within the past 3 months 9) Subjects referred for removal of previously diagnosed colorectal polyps or tumors 10) Subjects who refuse to sign the informed consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The success rate(A or B) based on the Harefield Cleansing Scale (HCS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of Harefield Bowel Cleansing Score per Segment;Adenoma detcetion rate(ADR);Patient Compliance;Safety assessment(adverse event) | — |
Countries
Korea, Republic of
Contacts
Chosun University Hospital