Study Overview

Details

NCTId: NCT02109991

Status: Completed

Condition: Gastrointestinal Anastomosis

Study Type: Interventional

Sponsor: Colospan Ltd.

Study Description

Brief

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

Healthy Volunteers: No

Gender: All

Min Age: 18 Years

Contacts

Assuta Medical Center

Tel Aviv

69710

Israel

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