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 @ 7:17 PM
Ignite Modification Date:
2025-12-24 @ 7:17 PM
NCT ID:
NCT06597903
Eligibility Criteria:
Inclusion Criteria:
* Written informed consent must be obtained prior to inclusion
* Male or female
* Inpatients 18 to 60 years old with indication for complete colonoscopy
* Willing and able to complete the entire procedure and to comply with study instructions
* Females of childbearing potential must employ an adequate method of contraception.
Exclusion Criteria:
* Ileus
* Intestinal obstruction or perforation.
* Toxic megacolon.
* History of any colonic surgery.
* Cardiac Insufficiency (NYHA grad III and IV).
* Ischemic cardio vascular disease.
* Renal insufficiency (creatinine above 1.4 mg/100 ml).
* Cirrhosis of liver (child B or C).
* Known hypersensitivity to polyethylene glycols and/or Vitamin C.
* Concurrent participation in an investigational drug study or participation within 30 days of study entry.
* Females who are pregnant, nursing or planning a pregnancy. Females of child bearing potential not using reliable methods of contraception.
* Subject has a condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound the study results, or may interfere significantly.
* Abnormal laboratory values (clinically significant) for sodium, potassium, chloride, creatinine and hematocrit
* Untreated or uncontrolled arterial hypertension (max. \> 170 mmHg and min \> 100 mmgH).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06597903
Study Brief:
Protocol Section:
NCT06597903