The aim of this study is to compare the additional diagnostic yield (adenoma detection rate) of G-EYE colonoscopy with that of standard high definition colonoscopy.
ID
Source
Brief title
Condition
- Benign neoplasms gastrointestinal
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
G-EYE* colonoscopy detection rate of adenomas and serrated lesions compared to
the standard colonoscopy detection rate of the same.
Secondary outcome
Polyp and adenoma detection, procedure times and safety.
Background summary
Colorectal adenomas are the precursor lesions of colorectal cancers. Detection
and resection of adenomas during colonoscopy can prevent the development of
colorectal malignancies.
Approximately 30% of polyps are missed during Standard Colonoscopy (SC), e.g.,
due to polyps hidden behind colon folds and flexures. This work explores a
novel device and technique for increasing polyp and adenoma detection during
colonoscopy. It employs a unique balloon-colonoscope (G-EYE* Endoscope, Smart
Medical Systems Ltd., Ra*anana, Israel), comprising a standard colonoscope
having a reprocessable, permanently integrated balloon at its distal tip. The
G-EYE balloon-colonoscope does not require pre-procedure preparation, mounting
or use of any single-use accessory. Balloon pressure is controlled through a
unique inflation system providing pre-determined, user-selectable, anchoring
and intermediate (low) pressure levels. Furthermore, the balloon can be readily
inflated to anchoring pressure upon interventional need, thus stabilizing the
colonoscope in position, for faster and more controlled endoscopic
interventions.
Study objective
The aim of this study is to compare the additional diagnostic yield (adenoma
detection rate) of G-EYE colonoscopy with that of standard high definition
colonoscopy.
Study design
This is a multicenter, two-arm, randomized, open-label study. Patients
referred to colonoscopy for screening or surveillance workup, are randomized
into two groups. Group A undergoes standard colonoscopy; group B undergoes
G-EYE colonoscopy. During the G-EYE colonoscopy, the endoscope is inserted with
the balloon deflated until the cecum is reached. Then, the balloon is inflated
to intermediate pressure and the G-EYE colonoscope is withdrawn, thus
straightening intestinal folds, smoothening colon topography and improving
colon visibility. All detected polyps will be removed.
Participating hospitals include centers in Denmark, Germany, Israel, Poland,
Spain, Turkey, and the United Kingdom.
Intervention
The NaviAid* G-EYE System is intended for the optical visualization, diagnosis
and endoscopic treatment in the gastrointestinal tract. It is also intended for
positioning of the endoscope in the gastrointestinal tract. The system consists
of a normal Pentax coloscope, with an inflatable balloon attached around the
tip. This balloon will be inflated during withdrawel.
Study burden and risks
All included patients have a medical indication for performing a colonoscopy.
The general risk for complications, such as perforation, bleeding, and
infection/sepsis, apply to both conventional and G-EYE colonoscopy. This G-EYE
endoscoop is approved by the international standarization guidelines and had a
EU certificate. The risk of complications is comparable with the risk of
conventional endoscopes.
Assuming that the intervention (the G-EYE colonoscoop) has a better adenoma
detection rate, less adenomas will be missed in the intervention group,
theoratically leading to a smaller chance of developing a colorectal malignancy
in the future at the individual level.
Hayetsira St. 10
Ra'anana 43663
IL
Hayetsira St. 10
Ra'anana 43663
IL
Listed location countries
Age
Inclusion criteria
- Patiënts over 50 years old
- Referred to colonoscopy for screening, following positive FOBT testing, change of bowel habits or for surveillance colonoscopy (history of adenoma resection)
- The patient must understand and provide written consent for the procedure
Exclusion criteria
- Patients with inflammatory bowel disease, known polyposis syndrome, diverticulitis or toxic megacolon
- Patients with suspected chronic stricture potentially precluding complete colonoscopy
- Patients with a history of radiation therapy to abdomen or pelvis
- Pregnant or lactating female subjects
- Patients who are currently enrolled in another clinical investigation
- Patients with current oral or parenteral use of anticoagulants
- Patients with recent (within the last 3 months) coronary ischemia or CVA
- Previous colonic surgery (except for appendectomy)
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 |
|---|---|
| ClinicalTrials.gov | NCT01917513 |
| CCMO | NL50819.068.14 |