Evaluate accuracy of PillCam* COLON 2 system in detecting patients with colonicpolyps *6mm and *10 mm as compared to conventional colonoscopy.
ID
Source
Brief title
Condition
- Malignant and unspecified neoplasms gastrointestinal NEC
- Gastrointestinal neoplasms benign
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Accuracy parameters of PillCam* COLON 2 in detecting patients with colonic
polyps *6mm and *10 mm as compared to conventional colonoscopy.
Secondary outcome
1) Diagnostic yield of PillCam* COLON 2 in detecting colonic lesions as
compared to
conventional colonoscopy
2) Assessment of colon cleansing level at different colon segments for PillCam
and
Colonoscopy
3) Distribution of capsule excretion time up to 10 hours post ingestion based
on Rapid
videos
4) Capsule transit time within stomach, small bowel and colon based on Rapid
videos
5) Prevalence of polyps at different size categories and locations as detected
by
capsule
6) Prevalence of polyps at different size categories and locations as detected
by
conventional colonoscopy
7) RAPID reading time
8) Number, type and severity of adverse events
Background summary
Colorectal cancer (CRC) is one of the most common cancers in western countries.
Appropriate screening and surveillance could not only reduce the morbidity and
mortality of CRC but also its incidence. Conventional colonoscopy (CC) is
considered to be the best available method for the detection of adenomas and
CRC. However, this is an invasive and costly procedure, associated with a
procedural risk. The ideal test for screening and surveillance purposes should
be safe, less invasive and cheaper than CC, and with a high diagnostic
accuracy. Following the success of the small bowel capsule endoscopy, colon
capsule endoscopy (CCE) might be an attractive alternative for colon screening
and surveillance.
Study objective
Evaluate accuracy of PillCam* COLON 2 system in detecting patients with colonic
polyps *6mm and *10 mm as compared to conventional colonoscopy.
Study design
This study will evaluate the performance of PillCam* COLON 2 in visualization
of the colon as compared to conventional colonoscopy.
Up to 130 subjects will participate in this study. All subjects to be enrolled
in this study are indicated and scheduled to undergo colonoscopy based on their
clinical indication with no relation to the tested device. Each subject will
undergo examination by the PillCam Colon and conventional colonoscopy
procedure. The generated RAPID video will be reviewed by a physician blinded to
the results of the conventional colonoscopy and vice versa (the Colonoscopist
will be blinded to the capsule*s results). Finally the PillCam* COLON 2 results
will be compared with conventional colonoscopy results that will be regarded as
the *gold standard*. In cases of which capsule will detect significant finding
(polyp*6mm) and colonoscopy will be either normal or show only insignificant
findings, the subjects will be offered a 2nd colonoscopy to verify and remove
the polyp that was initially detected by the capsule. In addition, procedures
outcome will be analyzed with regard to the study objectives and end points.
Study burden and risks
A risk of videocapsule endoscopy is retention of the capsule. In patients
without (suspected) intestinal stenosis or obstruction this risk is negligible.
To date no adverse events were reported with CCE.
As for the conventional colonoscopy, colon preparation with laxatives and an
adjusted diet is needed for colon capsule endoscopy. In this study the
conventional colonoscopy will be performed as soon as the capsule has left the
body or the battery is empty (after 10 hours). The conventional colonoscopy
will be performed the same day or at last the next morning. Only in the last
case extra laxatives are needed to keep the colon well prepared for the
conventional colonoscopy.
New Industrial Park
Yoqneam
Israel
New Industrial Park
Yoqneam
Israel
Listed location countries
Age
Inclusion criteria
Patients referred to colonoscopy for at least one of the following reasons:
- Colorectal cancer screening for age *50
- Clinical symptoms such as: rectal bleeding, hematochezia, melena,
positive FOBT, recent change of bowel habits for age *50
- Positive findings in the left colon during sigmoidoscopy(e.g. Polyp *10mm)
- Personal history of polyps that were removed at least 3 years ago
Exclusion criteria
1. < 18years, > 80 Years
2. Subject has dysphagia or any swallowing disorder
3. Subject has congestive heart failure
4. Subject has high risk of renal insufficiency associated with the use of sodium
phosphate
5. Subject is not eligible for colon preparation due to the presence of underlying
conditions based on the clinical judgment of the investigator
6. Subject has any allergy or other known contraindication to the medications
used in the study
7. Surgical intestinal anastomosis
8. Subject has a cardiac pacemaker or other implanted electro medical device.
9. Subject is expected to undergo MRI examination within 7 days after ingestion
of the capsule.
10. Known or suspected gastro-intestinal obstruction
11. Subject has known delayed gastric emptying
12. Women who are either pregnant at the time of screening, or are of childbearing
potential and do not practice medically acceptable methods of
contraception.
13. Subject currently participating in another clinical study
14. No informed consent, or inability to understand patient information and/ or give informed consent.
Design
Recruitment
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 | NL30940.018.09 |