Gastrointestinal Anastomosis Clinical Trial
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
| Verified date | July 2017 |
| Source | Colospan Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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).
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | October 2017 |
| Est. primary completion date | October 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ziekenhuis Oost-Limburg | Genk | |
| Belgium | UZ Gent | Gent | |
| Croatia | KBC Zagreb | Zagreb | |
| Hungary | Jahn Ferenc Hospital | Budapest | |
| Hungary | National Institute of Oncology | Budapest | |
| Israel | Soroka Medical Center | Beer-Sheva | |
| Israel | Rabin Medical Center | Petah Tikva | |
| Israel | Assuta Medical Center | Tel Aviv |
| Lead Sponsor | Collaborator |
|---|---|
| Colospan Ltd. |
Belgium, Croatia, Hungary, Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Rate of adverse events, and device related complications | During surgical procedure and up to 30 days (+/- 5) | ||
| Secondary | Occurrence of anastomotic leakage when the CG-100 is used | Up until device removal day (10 days +/-1) | ||
| Secondary | Position of the device (internal sheath) | Device removal day (10 days +/-1) | ||
| Secondary | Assessment of the device's application technique ease of placement and extraction of the device performance | Device removal day (10 days +/-1) | ||
| Secondary | Determine subject tolerability of the device | Device removal day (10 days +/- 1) |