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:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-25 @ 2:26 AM
NCT ID:
NCT04457934
Eligibility Criteria:
Inclusion Criteria:
* • Suspicion or history of IBD
* Screening colonoscopy
* Indication for colonoscopy
* Age 18-75 years
* Written informed consent
Exclusion Criteria:
* • Pregnancy or lactating
* Lower gastrointestinal bleeding with hemodynamic instability
* Bowel obstruction
* ASA \>3
* Not sufficiently corrected anticoagulation disorders
* Plenvu must not be taken:
* if you are allergic (hypersensitive) to the active ingredients or any of the other ingredients of this medicine;
* if you have a blockage (obstruction) in the digestive tract.
* if you have a breakthrough (perforation) in the wall of the digestive tract;
* if you suffer from intestinal obstruction (Ileus);
* if you suffer from a disturbance of gastric emptying (e.g. gastroparesis, gastric retention);
* if you suffer from phenylketonuria. Phenylketonuria is a congenital metabolic disease in which phenylalanine cannot be processed by your body. Plenvu contains aspartame as a source of phenylalanine;
* if you suffer from glucose-6-phosphate dehydrogenase deficiency;
* if you suffer from acute colon enlargement (toxic megacolon).
* Warnings and precautions
o You should tell your doctor about the following circumstances before taking Plenvu:
* if you have heart problems and/or arrhythmias;
* if you have kidney problems and/or suffer from dehydration;
* if you have stomach or intestinal problems, including intestinal inflammation;
* if you have difficulty or discomfort when swallowing liquids;
* if you have high or low levels of electrolyte (e.g. sodium, potassium);
* if you have other diseases (e.g. convulsions).
* Pregnancy and lactation o There are no data on the use of Plenvu during pregnancy or lactation and is therefore not recommended.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT04457934
Study Brief:
Protocol Section:
NCT04457934