Status:
UNKNOWN
Safety and Performance of the CG-100 in Patients Undergoing Colorectal Surgery.
Lead Sponsor:
Colospan Ltd.
Conditions:
Colorectal Surgery
Eligibility:
All Genders
22-75 years
Phase:
NA
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 colorecta...
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 patien...
Eligibility Criteria
Inclusion
- The patient is willing to comply with protocol-specified follow-up evaluations
- Patient 22-75 years of age at screening
- 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
- 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
- Preoperative
- 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.
- Patient surgical treatment is acute (not elective)
- Patient has local or systemic infection at the time of intervention (e.g., peritonitis)
- 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 classification \> 3
- Albumin \< 30 g/liter
- Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease
- BMI ≥ 40
- Subject is going through another surgical procedure (other than ileostomy or adhesiolysis) during the surgery.
- Patient is participating in another clinical trial within 30 days of screening
- Patient has been taking regular steroid medication in the last 6 months.
- Patient has contraindications to general anesthesia
- Patient has preexisting sphincter problems
- Patient has evidence of extensive local disease in the pelvis
- Any condition which in the opinion of the investigator may jeopardize the patient's safe participation Intraoperative (prior to device deployment)
- Anastomosis is located more than 20 cm from the anal verge
- Internal diameter lumen of the colon is smaller than 25 mm or larger than 34 mm
- Blood loss (\> 500 cc)
- Anastomosis was not performed for any reason other than consequences as a result of use of the study device -
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2019
Estimated Enrollment :
137 Patients enrolled
Trial Details
Trial ID
NCT03423485
Start Date
January 1 2018
End Date
July 31 2019
Last Update
October 4 2018
Active Locations (5)
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1
Hospital Beaujon
Paris, Clichy, France, 92110
2
University Hospital of Hamburg
Hamburg, Germany
3
Soroka Medical Center
Beersheba, Israel, 85025
4
Carmel Medical Center
Haifa, Israel