NCT07046468

Brief 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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 1, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

August 29, 2025

Status Verified

February 1, 2025

Enrollment Period

8 months

First QC Date

March 26, 2025

Last Update Submit

August 28, 2025

Conditions

Ulcerative Colitis (UC)Colorectal Cancer (CRC)

Keywords

Ulcerative ColitisColorectal cancerSensorRedoxOxidation reduction potentialIngestibleSensor pillInflammatory bowel disease

Outcome Measures

Primary Outcomes (7)

  • Intestinal ORP measurements

    ORP profile in the colon using the GISMO GEN1 System in patients with UC or CRC.

    Baseline and at 3 months after start of treatment.

  • Disease activity (SCCAI)

    UC disease activity as determined by the Simple Clinical Colitis Activity Index

    Baseline and 3 months after start of treatment.

  • Disease activity (FC)

    UC disease activity as determined by the faecal calprotectin (in microgram/gram)

    Baseline and at 3 months after treatment start.

  • Tumor stage

    TNM tumor stage as recorded in pathology report.

    Directly after surgical resection

  • Tumor size

    Tumor size as recorded in surgery report.

    Directly after surgical resection

  • Tumor resection margin status

    Residual tumor at the primary site after surgical resection as classified in pathology report.

    Directly after surgical resection

  • Tumor differentiation grade

    Tumor differentiation grade as recorded in pathology report.

    Directly after surgical resection

Secondary Outcomes (6)

  • Intestinal pH

    From enrollment to 3 months after start of treatment.

  • Area of inflammation

    Directly after intestinal ultrasound.

  • Tumour location

    Directly post-surgery.

  • Ingestible transit time.

    Baseline and at 3 months after start of treatment.

  • Data coverage

    Baseline and at 3 months after start of treatment

  • +1 more secondary outcomes

Study Arms (2)

Ulcerative colitis

Device: Ingestion of sensor capsule (twice)Behavioral: Device evaluation questionnaireDevice: Wearing deviceBehavioral: Monitoring sensor capsule exitDevice: Placement of devices at homeDiagnostic Test: Follow-up intestinal ultrasound

Colorectal cancer

Device: Ingestion of sensor capsule (twice)Behavioral: Device evaluation questionnaireDevice: Wearing deviceBehavioral: Monitoring sensor capsule exitDevice: Placement of devices at home

Interventions

Ingestion of sensor capsule (twice)DEVICE

Ingestion of the GISMO GEN1 System, an ingestible sensor capsule which measures pH, temperature and oxidation reduction potential (ORP) in the intestines.

Also known as: GISMO GEN1 System
Colorectal cancerUlcerative colitis
Device evaluation questionnaireBEHAVIORAL

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

Colorectal cancerUlcerative colitis
Wearing deviceDEVICE

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

Colorectal cancerUlcerative colitis
Monitoring sensor capsule exitBEHAVIORAL

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.

Colorectal cancerUlcerative colitis
Placement of devices at homeDEVICE

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.

Colorectal cancerUlcerative colitis
Follow-up intestinal ultrasoundDIAGNOSTIC_TEST

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.

Ulcerative colitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

This study will be performed in outpatients ≥18 years old. Five patients will be included with moderately to severely active UC, starting new treatment; five patients with colorectal adenocarcinoma, planned for surgery.

You may qualify if:

  • (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.

You may not qualify if:

  • (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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud university medical center

Nijmegen, Gelderland, 6525GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Colitis, UlcerativeColorectal NeoplasmsInflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsRectal Diseases

Study Officials

  • Marjolijn Duijvestein, MD PhD

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lotte R Hazeleger, Master of Science

CONTACT

+31650008309lotte.hazeleger@radboudumc.nl

Marjolijn Duijvestein, MD PhD

CONTACT

marjolijn.duijvestein@radboudumc.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2025

First Posted

July 1, 2025

Study Start

July 1, 2025

Primary Completion

March 1, 2026

Study Completion

May 1, 2026

Last Updated

August 29, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

The data that supports the findings of this study can be made available upon request to the corresponding author within the regulations of the applicable regulations and ethical considerations.

Locations

NL(1)