Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT05570669
Eligibility Criteria:
Inclusion Criteria:
* Male / female patients
* outpatient, consecutively subjected to colonoscopy with an exam scheduled from 8.00 to 10.00
* Age between 18 and 75 years
* Written informed consent
Exclusion Criteria:
* Hypersensitivity and contraindications to the product under study, to the active ingredients or to any of the excipients.
Known severe renal insufficiency (Glomerular Filtration Rate (eGFR) \<30 ml / min / 1.73 m2)
* Presence of known chronic inflammatory bowel disease
* Previous digestive tract surgery
* Suspected gastrointestinal perforation
* History of congestive heart failure (NYHA class III or IV)
* Severe hepatic insufficiency or impairment (in the case of Child-Pugh Class C accurate verification of the patient's condition) indicated by transaminase values greater than 3 times the maximum normal value.
* Toxic colitis or toxic megacolon
* Suspected intestinal obstruction
* Patients enrolled in colorectal cancer screening programs
* Intestinal paralysis
* Documented electrolyte disturbances (Na, Cl, K, Ca or P outside normal limits)
* Recent symptomatic acute ischemic heart disease (\<6 months). Acute myocardial infarction and recent unstable angina within six months antecedents.
* Participation in a clinical trial in which an investigational drug was administered within 30 days or 5 half-lives of the study drug, whichever is longer.
* Documented state of pregnancy ascertained through positive pregnancy test
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT05570669
Study Brief:
Protocol Section:
NCT05570669