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 @ 6:30 PM
Ignite Modification Date:
2025-12-24 @ 6:30 PM
NCT ID:
NCT07046468
Eligibility Criteria:
Inclusion Criteria:
(For all participants:)
* Age ≥ 18 years old;
* willing and able to provide informed consent;
* defaecation pattern: generally at least one defaecation per 48 hours.
(For the UC group:)
* Diagnosis of UC confirmed by clinical, endoscopic, and/or histological evidence prior to screening as per standard criteria;
* moderately to severely active UC determined by intestinal ultrasound (bowel wall thickness (BWT) \> 3 mm), starting treatment or requiring change in treatment due to non-response to their existing treatment;
* starting or optimizing treatment for colitis (including aminosalicylates, oral corticosteroids, thiopurines, biologics and small molecules).
(For the CRC group:)
* Diagnosis of non-obstructing non-locally advanced colorectal adenocarcinoma;
* ready/planned for surgery of CRC.
Exclusion Criteria:
(For all participants:)
* Body mass index (BMI) \> 30 kg/m\^2;
* known obstruction, stricture or stenosis in the gastrointestinal tract not attributable to current inflammation or tumour, potentially blocking ingestible passage. Determined as per discretion of gastroenterologist/oncologist using standard procedural clinical diagnostic or imaging techniques;
* history of complex bowel resection or recent intra-abdominal surgery (\< 3 months);
* known abdominal adhesions;
* swallowing disorders, including achalasia or oropharyngeal dysfunction;
* ongoing infections;
* known to be pregnant, lactating or actively trying to get pregnant (self-reported);
* short bowel syndrome or ostomy;
* only parenteral diet;
* pacemaker or other implantable electronic devices;
* planned magnetic resonance imaging (MRI) procedure during the ingestible meaurement period;
* unwilling to undergo an X-ray examination (in the case ingestible exit cannot be confirmed);
* participation in other medical interventional/Wet medisch-wetenschappelijk onderzoek (WMO)-compliant reearch;
* participant is working (as medical personnel) in a professional healthcare facility (intensive care, emergency room, surgery rooms, clinics, patient rooms), military area (e.g. submarine, near radar installation), or heavy industrial area (e.g. power plants, automotive, mining, refineries) during the duration of the clinical investigation.
(For the CRC group:)
* Diagnosis or strong suspicion of IBD;
* planned treatment with adjuvant chemotherapy or radiotherapy.
(For the UC population:)
* Diagnosis or strong suspicion of colorectal adenocarcinoma;
* use of rectal foam/enema during the measurement period.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07046468
Study Brief:
Protocol Section:
NCT07046468