None listed
Conditions
Interventions
Drug : (1) Experimental group (modified CleanViewAL, TJP-008):
First dose (evening before the test): 500mL of prepared solution (2 packets of A / 2 packets of B) + 500mL of water
Second dose (morning
Sponsors
The Catholic University of Korea, St. Vincent's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A patient who is deemed to require an endoscopy due to complaints of digestive symptoms and meets all of the following selection criteria: (1) Adult males and females between the ages of 19 and 74 (2) Individuals scheduled to undergo upper/lower gastrointestinal endoscopy (3) Body Mass Index (BMI) = 30 (4) Voluntarily consents to participate in this clinical trial and signs the consent form.
Exclusion criteria
Exclusion criteria: Individuals who meet any of the following criteria: (1) History of the following surgeries, medical conditions, or comorbidities: - Dehydration -Colorectal resection - Gastrointestinal obstruction (intestinal obstruction, gastrointestinal obstruction, etc.), perforation, or gastric outlet obstruction (gastroparesis, etc.) - Inflammatory bowel disease (ulcerative colitis, Crohn's disease, etc.) or toxic megacolon - Regular or ongoing use of laxatives or stool softeners, or severe constipation requiring physical intervention (e.g. more than 3 bowel movements per week) - Severe cardiac disease (NYHA class 3,4 heart failure, acute coronary artery disease within 24 weeks prior to screening, clinically significant arrhythmias, hypertrophic obstructive cardiomyopathy, valvular heart disease, aortic disease, and peripheral vascular disease) - History of cardiac arrest - Blood coagulation disorders - Severe chronic kidney disease (eGFR or CrCl = 2 x upper limit of normal - AST or ALT >= 3 x upper limit of normal (3) Pregnant or breastfeeding women, or individuals planning to become pregnant during the screening period (4) Glucose-6-phosphate dehydrogenase deficiency patients (5) Patients with confirmed or suspected phenylketonuria (6) Patients with hypersensitivity or allergy to any component of the investigational product during the clinical trial (7) Individuals requiring concomitant use of prohibited drugs during the clinical trial period (8) Individuals who have received investigational drugs or medical devices in other clinical trials (9) Other individuals who are deemed unsuitable for participation in the study by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects evaluated as "successful cleansing" on the Harefield Cleansing Scale (HCS) | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of subjects evaluated as "high quality cleansing" and the average score for each of the 5 segments on the Harefield Cleansing Scale (HCS);The proportion of subjects evaluated as "successful cleansing" on the Boston bowel preparation scale (BBPS);The proportion of subjects evaluated as "high quality cleansing" and the average score for each of the 3 segments on the Boston bowel preparation scale (BBPS);The proportion of subjects in whom one or more polyps/adenomas were detected in the entire colon and the ascending colon.;Adherence for investigational product;Satisfaction assessment;Gastric food/fluid retention;Treatment-emergent adverse event (TEAE) | — |
Countries
Korea, Republic of
Contacts
Public Contactsoyoun Kim
The Catholic University of Korea, St. Vincent's Hospital
Outcome results
None listed