Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.

Colorectal Surgery Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03423485
• Other study ID #: CLD-017
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: January 2018
• Source: Colospan Ltd.
• Contact: Ilia Pinsk, MD
• Phone: +972-8-6400561
• Email: IliaPi[@]clalit.org.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 137
• Est. completion date: July 31, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 75 Years

Eligibility

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 -

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Device:
• CG-100 Intraluminal Bypass Device
Intended to reduce contact of fecal content with an anastomotic site , following colorectal surgery.

Locations

Country	Name	City	State
France	Hospital Beaujon	Paris	Clichy
Germany	University Hospital of Hamburg	Hamburg
Israel	Soroka Medical Center	Beer-Sheva
Israel	Carmel Medical Center	Haifa
Switzerland	CHUV, University Hospital Vaudois	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
Colospan Ltd.

Countries where clinical trial is conducted

France,  Germany,  Israel,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Leak proof seal with at least 85% success at balloon-Mucosa interface as evidenced by contrast through the device lumen without extravasation and no illumination of the anastomosis.	device removal day (10 days +/-1)
Secondary	To assess the safety profile of the CG-100 Intraluminal Bypass Device.	Rate of adverse events	During surgical procedure and up to 30 days (+/- 5) ]
Secondary	To evaluate Performance in terms of clinical anastomotic leakage based on clinical symptoms of the patient such as fever, blood tests.	The patient will be followed for 10±1 days to assess the occurrence of clinical anastomotic leakage based on positive clinical symptoms of the patient such as fever, blood tests, while the CG-100 Intraluminal Bypass Device is in situ.; In addition, at 10±1 days a rectal contrast enema will be done to assess the occurrence of radiological anastomotic leakage.	Device deployment until device removal day (10 days +/-1)
Secondary	Successful positioning and maintenance of device position	Position of internal sheath during rectal contrast enema based on radiological demonstration	10+1 days post-surgery before device removal
Secondary	To assess the ease of the device's application and removal	Assessment of the ease of the device's application will be done using a Device application use questionnaire completed by the surgeon at Procedure Day. The ease of device removal will also be assessed on Discharge Day, using the Device application use questionnaire	Surgical procedure and Device removal day (10 days +/-1)
Secondary	To assess the safety profile of the CG-100 Intraluminal Bypass Device.	Rate of device related complications	Up to 30 (+/- 5) days
Secondary	To assess the occurrence of radiological anastomotic leakage, evaluated by performing a rectal contrast enema .	At 10±1 days a rectal contrast enema will be done to assess the occurrence of radiological anastomotic leakage.	At 10±1 days