Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer

RecruitingOBSERVATIONAL
Enrollment

10

Participants

Timeline

Start Date

July 1, 2025

Primary Completion Date

March 1, 2026

Study Completion Date

May 1, 2026

Conditions
Ulcerative Colitis (UC)Colorectal Cancer (CRC)
Interventions
DEVICE

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.

BEHAVIORAL

Device evaluation questionnaire

A 16-item online questionnaire to assess participant's experiences with the ingestible sensor capsule after the study measurements.

DEVICE

Wearing device

Participants will wear a small device on a soft belt around their waist during study measurements with the sensor capsules.

BEHAVIORAL

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.

DEVICE

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.

DIAGNOSTIC_TEST

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.

Trial Locations (1)

6525GA

RECRUITING

Radboud university medical center, Nijmegen

All Listed Sponsors
collaborator

Stichting IMEC-NL

OTHER

lead

Radboud University Medical Center

OTHER

NCT07046468 - Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer | Biotech Hunter | Biotech Hunter