Clinical trial NCT03423485: Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.
Official title: A Prospective, Multi-center, Single-arm, Open-label Study Designed to Evaluate Safety and Performance Profile of the CG-100 Intraluminal Bypass Device in Patients Undergoing Colorectal Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Surgery
Keywords: Colorectal Surgery
Lead sponsor: Colospan Ltd.
Sponsor class: INDUSTRY
First posted: 2018-02-06
Enrollment: 137
Sex: ALL
Minimum age (years): 22
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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)

Detailed description: Colospan is initiating a pivotal clinical prospective, multi-center, single-arm, open-label study designed to evaluate safety and performance profile of the CG-100 Intraluminal Bypass Device in patients undergoing colorectal surgery study.

Up to 137 patients (in total) will be enrolled in up to 12 sites in Europe, Israel and USA.

Study objectives Primary Objective: To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic) Secondary Objectives: To evaluate Performance in terms of clinical and radiological anastomotic leakage Successful positioning and maintenance of device position To assess the ease of the device's application and removal Safety: To assess the safety profile of the CG-100 Intraluminal Bypass Device.

Eligibility criteria: Inclusion Criteria:

1. The patient is willing to comply with protocol-specified follow-up evaluations
2. Patient 22-75 years of age at screening
3. The patient is scheduled to undergo an elective colorectal surgery (open, laparoscopic, or robotic) which will require the creation of an anastomosis, maximally 20 cm proximal from the anal verge
4. The patient or legally authorized representative, has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the appropriate Medical Ethics Committee (EC) or Institutional Review Board (IRB).

Exclusion Criteria:

Preoperative

1. Pregnant or nursing female subjects. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to surgical procedure per site standard test.
2. Patient surgical treatment is acute (not elective)
3. Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
4. 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
5. Patients with ASA classification \> 3
6. Albumin \< 30 g/liter
7. Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
8. BMI ≥ 40
9. Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery.
10. Patient is participating in another clinical trial within 30 days of screening
11. Patient has been taking regular steroid medication in the last 6 months.
12. Patient has contraindications to general anesthesia
13. Patient has preexisting sphincter problems
14. Patient has evidence of extensive local disease in the pelvis
15. Any condition which in the opinion of the investigator may jeopardize the patient's safe participation Intraoperative (prior to device deployment)
16. Anastomosis is located more than 20 cm from the anal verge
17. Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm
18. Blood loss (\> 500 cc)
19. Anastomosis was not performed for any reason other than consequences as a result of use of the study device -

Primary outcomes:
measure: To evaluate the performance of the CG-100 Intraluminal Bypass Device, in reducing contact of fecal content with an anastomotic site in patients undergoing colorectal surgery (open, robotic, or laparoscopic)
timeFrame: device removal day (10 days +/-1)
Secondary outcomes:
measure: To assess the safety profile of the CG-100 Intraluminal Bypass Device.
timeFrame: During surgical procedure and up to 30 days (+/- 5) ]
measure: To evaluate Performance in terms of clinical anastomotic leakage based on clinical symptoms of the patient such as fever, blood tests.
timeFrame: Device deployment until device removal day (10 days +/-1)
measure: Successful positioning and maintenance of device position
timeFrame: 10+1 days post-surgery before device removal
measure: To assess the ease of the device's application and removal
timeFrame: Surgical procedure and Device removal day (10 days +/-1)
measure: To assess the safety profile of the CG-100 Intraluminal Bypass Device.
timeFrame: Up to 30 (+/- 5) days
measure: To assess the occurrence of radiological anastomotic leakage, evaluated by performing a rectal contrast enema .
timeFrame: At 10±1 days
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Beaujon
state: Clichy
city: Hamburg
country: Germany
facility: University Hospital of Hamburg
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Lausanne
country: Switzerland
facility: CHUV, University Hospital Vaudois
Study officials:
affiliation: Soroka University Medical Center
name: Ilia Pinsk, MD
role: PRINCIPAL_INVESTIGATOR
References: