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

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

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).

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Anastomosis
• Intervention / Treatment: Device: CG-100 device

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Genk, Belgium, 3600
    • Ziekenhuis Oost-Limburg
  • Gent, Belgium, 9000
    • UZ Gent
• Croatia
  • Zagreb, Croatia, 10000
    • KBC Zagreb
• Hungary
  • Budapest, Hungary, 1204
    • Jahn Ferenc Hospital
  • Budapest, Hungary, H-112
    • National Institute of Oncology
• Israel
  • Beer-Sheva, Israel, 85025
    • Soroka Medical Center
  • Petah Tikva, Israel, 49100
    • Rabin Medical Center
  • Tel Aviv, Israel, 69710
    • Assuta Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CG-100 device	Device: CG-100 device; Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
Determine subject tolerability of the device	Device removal day (10 days +/- 1)

Collaborators and Investigators

• Sponsor: Colospan Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2014
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: April 8, 2014
• First Submitted That Met QC Criteria: April 8, 2014
• First Posted (Estimate): April 10, 2014

Study Record Updates

• Last Update Posted (Actual): December 8, 2017
• Last Update Submitted That Met QC Criteria: December 7, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: CLD-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No