10
Participants
Start Date
July 1, 2025
Primary Completion Date
March 1, 2026
Study Completion Date
May 1, 2026
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.
RECRUITING
Radboud university medical center, Nijmegen
Stichting IMEC-NL
OTHER
Radboud University Medical Center
OTHER