Ignite Creation Date:
2025-12-24 @ 6:30 PM
Ignite Modification Date:
2025-12-29 @ 4:33 AM
Study NCT ID:
NCT07046468
Status:
RECRUITING
Last Update Posted:
2025-08-29
First Post:
2025-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smart Pill for Measuring Gut Health in Colon Inflammation and Colon Cancer
Sponsor:
Radboud University Medical Center
Organization:
Study Overview
Official Title:
Measurement of Oxidation Reduction Potential in the Colon Using an Ingestible Sensor in Patietns With Ulcerative Colitis (UC) and Colorectal Cancer (CRC)
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPIRIT
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).
* 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).
Detailed Description:
Rationale: The gold standard diagnostic tool for inflammatory bowel disease (IBD) and colorectal carcinoma (CRC) is endoscopy, which can be burdensome for patients. The future of IBD care demands novel, minimally invasive biomarkers for personalized care and CRC screening programs could greatly benefit from new minimally invasive diagnostic tools. Oxidative stress plays a significant role in the progression of gut inflammation and colorectal cancer. Using an ingestible sensor, we aim to measure oxidation-reduction potential (ORP) directly in the gut. We hypothesize that it is feasible to measure intestinal ORP with an ingestible sensor and expect that ORP levels are elevated in patients with active ulcerative colitis (UC) and CRC before treatment, compared to after treatment.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NL88151.091.24 | OTHER | Netherlands Trial Register (NTR) | View |