The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or laparoscopic).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site
Ziekenhuis Oost-Limburg
Genk, Belgium
UZ Gent
Ghent, Belgium
KBC Zagreb
Zagreb, Croatia
Jahn Ferenc Hospital
Budapest, Hungary
Rate of adverse events, and device related complications
Time frame: During surgical procedure and up to 30 days (+/- 5)
Occurrence of anastomotic leakage when the CG-100 is used
Time frame: Up until device removal day (10 days +/-1)
Position of the device (internal sheath)
Time frame: Device removal day (10 days +/-1)
Assessment of the device's application technique ease of placement and extraction of the device performance
Time frame: Device removal day (10 days +/-1)
Determine subject tolerability of the device
Time frame: Device removal day (10 days +/- 1)
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National Institute of Oncology
Budapest, Hungary
Soroka Medical Center
Beersheba, Israel
Rabin Medical Center
Petah Tikva, Israel
Assuta Medical Center
Tel Aviv, Israel