Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery

Not Applicable

Completed

• Conditions: Gastrointestinal Anastomosis
• Interventions: Device: CG-100 device

• Registration Number: NCT02109991
• Lead Sponsor: Colospan Ltd.

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

Not available

Study Timeline

• Study Start: 2014-03
• Study First Submitted: 2014-04-08
• Study First Submitted QC: 2014-04-08
• Study First Posted: 2014-04-10
• Status Verified: 2017-07
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-12-07
• Last Update Posted: 2017-12-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CG-100 device	CG-100 device	-

Primary Outcome Measures

Name	Time	Method
Rate of adverse events, and device related complications	During surgical procedure and up to 30 days (+/- 5)

Secondary Outcome Measures

Name	Time	Method
Determine subject tolerability of the device	Device removal day (10 days +/- 1)
Occurrence of anastomotic leakage when the CG-100 is used	Up until device removal day (10 days +/-1)
Position of the device (internal sheath)	Device removal day (10 days +/-1)
Assessment of the device's application technique ease of placement and extraction of the device performance	Device removal day (10 days +/-1)

Trial Locations

Locations (8)

Soroka Medical Center; 🇮🇱 Beer-Sheva, Israel

UZ Gent; 🇧🇪 Gent, Belgium

Jahn Ferenc Hospital; 🇭🇺 Budapest, Hungary

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

National Institute of Oncology; 🇭🇺 Budapest, Hungary

KBC Zagreb; 🇭🇷 Zagreb, Croatia