Measurement of intestinal oxidation-reduction potential using a smart sensing ingestible and its relation to active UC and CRC.
ID
Source
Brief title
Condition
- Gastrointestinal inflammatory conditions
- Gastrointestinal neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Measurement of ORP profile in the colon using the GISMO GEN1 System in
patients with UC or CRC before and after treatment.
- To relate intestinal ORP profile in the colon to known tumor location or area
of inflammation, for respectively CRC and UC.
- To compare intestinal ORP and pH profiles before and after medical treatment
or surgical resection for respectively UC and CRC.
- To relate intestinal ORP profile to measures of disease activity in UC,
including fecal calprotectin (FC).
- To compare intestinal ORP and pH profiles of UC and CRC patients to those of
healthy controls.
- To continue assessment of the feasibility of the GISMO GEN1 System in humans
with GI tract related disorders by studying the ingestible transit time, data
coverage, partici-pant experience, and serious adverse events (if applicable).
Secondary outcome
NA
Background summary
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 ingestible, we aim to measure oxidation-reduction potential
(ORP) directly in the gut. We hypothesize that ORP levels are elevated in
patients with active ulcerative colitis (UC) and CRC before treatment, compared
to after treatment.
Study objective
Measurement of intestinal oxidation-reduction potential using a smart sensing
ingestible and its relation to active UC and CRC.
Study design
Observational study with invasive measurements
Study burden and risks
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 abdominal
X-ray will confirm whether the device is still in the gastrointestinal tract.
If visible on the abdominal X-ray, a medical specialist will determine further
action, which may include laxatives or surgery, with costs covered by the
research team. If abdominal 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.
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Geert Grooteplein Zuid 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
- age >= 18 years
- diagnosed with colorectal cancer and planned for surgerical tumour resection
OR
- diagnosed with ulcerative colitis, with active inflammation as determined by
increased bowel wall thickness on intestinal ultrasound
Exclusion criteria
- BMI > 30 kg/m2
- 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.
- Pregnant, lactating or trying to get pregnant
- Pacemaker or other implantable electronic devices
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL88151.091.24 |