Clinical trial NCT02109991: Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
Official title: A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Anastomosis
Lead sponsor: Colospan Ltd.
Sponsor class: INDUSTRY
First posted: 2014-04-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

* The patient is scheduled to undergo an elective colorectal surgery (open or laparoscopic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
* The patient is willing to comply with protocol-specified follow-up evaluations
* The patient signed Informed Consent

Exclusion Criteria:

* Pregnant or nursing female subjects
* Patient surgical treatment is acute (not elective)
* Patient has infections at the time of intervention
* Major surgical or interventional procedures within 30 days prior to this study or planned surgical or interventional procedures within 30 days of entry into this study
* Patients with ASA (American Society of Anesthesiologists) classification \> 3
* diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
* Patient is participating in another clinical trial within 30 days of screening
* Patient has been taking regular steroid medication in the last 6 months
* Contraindications to general anesthesia
* Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis
* Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm
* Blood loss (\> 500 cc)
* Leak test failure during surgery
* Any condition or surgical incidence where the device deployment can jeopardize the patient's safety or interferes with study outcome per the discretion of the investigator

Primary outcomes:
measure: Rate of adverse events, and device related complications
timeFrame: During surgical procedure and up to 30 days (+/- 5)
Secondary outcomes:
measure: Occurrence of anastomotic leakage when the CG-100 is used
timeFrame: Up until device removal day (10 days +/-1)
measure: Position of the device (internal sheath)
timeFrame: Device removal day (10 days +/-1)
measure: Assessment of the device's application technique ease of placement and extraction of the device performance
timeFrame: Device removal day (10 days +/-1)
measure: Determine subject tolerability of the device
timeFrame: Device removal day (10 days +/- 1)
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg
city: Gent
country: Belgium
facility: UZ Gent
city: Zagreb
country: Croatia
facility: KBC Zagreb
city: Budapest
country: Hungary
facility: Jahn Ferenc Hospital
city: Budapest
country: Hungary
facility: National Institute of Oncology
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Assuta Medical Center
Study officials:
References: