Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer
NCT ID: NCT07046468
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
10 participants
OBSERVATIONAL
2025-07-01
2026-05-01
Brief Summary
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* 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).
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Detailed Description
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Objective: Measurement of intestinal oxidation-reduction potential using a smart sensing ingestible and its relation to active UC and CRC.
Study design: Observational, exploratory study with invasive measurements.
Study population: 5 patients ≥ 18 years of age with UC and 5 patients ≥ 18 years of age with CRC
Main study parameters/endpoints: The main study parameter is colonic ORP profiles measured with the ingestible sensor ingestible compared before and after treatment for UC and CRC.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Risk associated with participation are deemed low. Medical or surgical treatment is not altered in any way. Patients with UC will receive an additional IUS. The GISMO GEN1 ingestible device (size 21.8 mm x 7.64 mm) is an investigational tool deemed safe for human use in clinical settings, with risks detailed in the IMDD. Device exit will be tracked via the temperature sensor of the ingestible sensor. If exit is not confirmed after 14 days, an X-ray will confirm whether the device is still in the gastrointestinal tract. If visible on the X-ray, a medical specialist will determine further action, which may include laxatives or surgery, with costs covered by the research team. If X-ray examination is necessary, the participant may experience a maximum radiation exposure of 0.10 mSv. Participant burden is low; time investment including study visits, device checks and questionnaire is estimated around 4 hours in total. Main burden is expected to be the continuous wearing of the base device as long as the ingestible sensor remains in the body.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Ulcerative colitis
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.
Colorectal cancer
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Stichting IMEC-NL
OTHER
Radboud University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Marjolijn Duijvestein, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Radboud university medical center
Nijmegen, Gelderland, Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL88151.091.24
Identifier Type: OTHER
Identifier Source: secondary_id
2024-17771
Identifier Type: -
Identifier Source: org_study_id
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