Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years and Over|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|Robert Bosch Medical Center|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Joerg G. Albert|
|Principal Investigator Affiliation||Robert Bosch Medical Center|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Inflammatory Bowel Diseases, Morbus Crohn|
People who contact a gastroenterologist because of persistent complaints like abdominal pain or diarrhea are suspicious having an inflammatory bowel disease and maybe meet the eligibility requirements for the study. After checking the inclusion and exclusion criteria further necessary data (medical history, secondary diagnoses, previous examinations, etc.) as well as laboratory parameters (especially signs of inflammation and fecal calprotectin) are collected. After being informed about the study and potential risks, all patients giving written informed consent and who meet the eligibility requirements will be randomized in an open-label manner (participant and investigator) in a 1:1 ratio to video capsule endscopy intervention or colonoscopy. A follow-up by phone to evaluate the state of health is planned after six months. The study center and established specialist practices are responsible for the study inclusion. There will be no recruitment by advertising. Only participants who are introducing themselves due to complaints are offered study participation.
Active Comparator: PICE
Participants receive a panintestinal video capsule endoscopy (PICE)
Active Comparator: Colonoscopy
Participants receive an (Ileo-)Colonoscopy
Device: - Panintestinal video capsule endoscopy
Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic
Device: - Colonoscopy
Performing a standard colonoscopy using the colonoscope available in the study center
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.