Ingestion of sensor capsule (twice)Device evaluation questionnaireWearing deviceMonitoring sensor capsule exitPlacement of devices at homeFollow-up intestinal ultrasound
Ingestion of sensor capsule (twice): Ingestion of the GISMO GEN1 System, an ingestible sensor capsule which measures pH, temperature and oxidation reduction potential (ORP) in the intestines.
Device evaluation questionnaire: A 16-item online questionnaire to assess participant's experiences with the ingestible sensor capsule after the study measurements.
Wearing device: Participants will wear a small device on a soft belt around their waist during study measurements with the sensor capsules.
Monitoring sensor capsule exit: Participants are instructed to press a button on the wearable device when they use the toilet for defaecation and wait with flushing to toilet until the wearable device indicates (using colored LEDs) that the toilet can be flushed and 1) that the sensor capsule is still in the body and study measurements continue or 2) that the sensor capsule has likely been excreted via the feces and the participant has to contact the research team to confirm exit.
Placement of devices at home: Participants do not have to wear the device around the waist during sleeping. For optimal monitoring of sensor capsule exit during the nights, a second device will be placed on the participant's bedside table/close to the bed and a third device will be placed close to the toilet that the participant usually uses during the night.
Follow-up intestinal ultrasound: At 3 months after treatment initiation, participants with ulcerative colitis will undergo a follow-up intestinal ultrasound (IUS) (non-endoscopic) outside of routine care to assess treatment response.
Study summary
The goal of this observational pilot study with invasive measurements is to explore whether an ingestible sensor pill can be of use in diagnosis or monitoring of disease in patients with ulcerative colitis or colorectal cancer. The main questions it aims to answer are:
* which changes in bowel environment can the sensor pill measure in ulcerative colitis and colorectal cancer before and after treatment?
* how practical, effective and user-friendly is the sensor pill for measuring bowel environment in patients with bowel disease?
Participants will:
* take one sensor pill before treatment and take one sensor pill three months after (start of) treatment;
* monitor sensor pill bowel exit using a small wearable device;
* answer a questionnaire on experience with the sensor pill;
* receive an extra bowel ultrasound (non-endoscopic) three months after start of treatment (only for participants with ulcerative colitis).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Intestinal ORP measurements — Baseline and at 3 months after start of treatment. ORP profile in the colon using the GISMO GEN1 System in patients with UC or CRC.
Disease activity (SCCAI) — Baseline and 3 months after start of treatment. UC disease activity as determined by the Simple Clinical Colitis Activity Index
Disease activity (FC) — Baseline and at 3 months after treatment start. UC disease activity as determined by the faecal calprotectin (in microgram/gram)
Tumor stage — Directly after surgical resection TNM tumor stage as recorded in pathology report.
Tumor size — Directly after surgical resection Tumor size as recorded in surgery report.
Tumor resection margin status — Directly after surgical resection Residual tumor at the primary site after surgical resection as classified in pathology report.
Tumor differentiation grade — Directly after surgical resection Tumor differentiation grade as recorded in pathology report.
Trial sites (1)
Facility
City
Region
Status
Radboud university medical center
Nijmegen
Gelderland
Recruiting
More Radboud University Medical Center trials in the Netherlands
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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