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 - 75 Years|
- - Adults with established diagnosis of CD with ileal, colonic or ileo-colonic disease aged 18-75 years.
- - Patients of RMH IBD clinic and other specialty clinics where assessment of mucosal healing is clinically indicated this includes: Patients who have had Anti TNF induction therapy 6-12 months prior to commencement of this study AND/OR Patients referred for colonoscopy to assess mucosal disease status with a view to treatment escalation based on the findings.
Exclusion Criteria:Patients must not:
- - Have known/suspected gastrointestinal obstruction.
- - Have swallowing disorder.
- - Have a known oesophageal stricture.
- - Have severe gastroparesis.
- - Have dementia.
- - Have a cardiac pacemaker or other implanted medical device.
- - Have sever cardiac or renal insufficiency.
- - Have a previous allergy or contraindication to bowel preparation.
- - Be pregnant.
- - Prior major abdominal surgery.
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.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||Melbourne Health|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
Other: Anti TNF induction therapy 6-12 months
All subjects will be identified through The Royal Melbourne Hospital's IBD clinic, associated specialty clinics and the colonoscopy waiting list of The Royal Melbourne Hospital. The potential participants who have been commenced on Anti TNF induction therapy 6-12 months prior to commencement of the study will be identified. The potential participants identified in this way will be informed of the project at the time of contact and assessment; in some instances the potential participant will be informed of the project via telephone where subjects are remote. The potential participants will be provided an Ethically-approved information sheet at this time. Consent will be gained at the time of assessment.
Device: - PillCam® COLON 2 Capsule Endoscopy
Contact a Trial Team
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.