The study aims to determine the safety and efficacy of the steering module in a clinical setting.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoints are safety and efficacy.The primary study parameters are
the number of SAEs related to the procedure and the number of successful cecal
intubations.
Secondary outcome
Secondary parameters are intubation time, total procedure time and the
evaluation of the physician*s opinion on inspection effectiveness on a 5 point
Likert scale.
Background summary
The flexible colonoscope is an effective tool in diagnostics and small
therapeutic interventions of the digestive tract. However, controlling the
endoscope is difficult and advanced therapeutic interventions will demand even
more of the physician. Ruiter et al. (2012) introduced a remote steering module
for complex interventions. Preliminary studies showed this system is effective,
increases efficiency and raises satisfaction in a simulated environment. The
module should also allow safe and effective scope manipulation in order to
reach intervention sites throughout the bowel without the need to change
instruments. We expect the steering module to enable safe and effective
colonoscopy in patients.
Study objective
The study aims to determine the safety and efficacy of the steering module in a
clinical setting.
Study design
This is a prospective cohort feasibility study. It includes a two-step design
with a preliminary evaluation before continuing the second phase of the study.
Study burden and risks
There is no extra burden associated with participation. Risks of participation
could be in longer procedure time due to the learning aspect. The investigator
may decide to convert to the conventional steering principle in case of poor
visibility of the bowel wall or patient discomfort due to a prolonged procedure
time.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
Patients who are scheduled for a diagnostic colonoscopy exam.
Patients should be 18 years or older.
Exclusion criteria
patients not fulfilling standard criteria to undergo colonoscopy.
patients who had previous abdominal surggery.
patients in ASA class 3, 4 or 5.
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 | NL42931.018.13 |