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

NCT02109991 | Completed

• 1 other identifier: CLD-001
• Study Type: interventional
• Target: 60
• Locations: 4 countries
• Sites: 8

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).

Conditions

Gastrointestinal Anastomosis

Outcome Measures

Primary Outcomes (1)

• Rate of adverse events, and device related complications

  During surgical procedure and up to 30 days (+/- 5)

Secondary Outcomes (4)

• 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)

Study Arms (1)

CG-100 device

EXPERIMENTAL

Device: CG-100 device

Interventions

CG-100 device DEVICE

Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site

CG-100 device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Colospan Ltd.: lead

Study Sites (8)

Ziekenhuis Oost-Limburg

Genk, 3600, Belgium

Location

UZ Gent

Ghent, 9000, Belgium

Location

KBC Zagreb

Zagreb, 10000, Croatia

Location

Jahn Ferenc Hospital

Budapest, 1204, Hungary

Location

National Institute of Oncology

Budapest, H-112, Hungary

Location

Soroka Medical Center

Beersheba, 85025, Israel

Location

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

Assuta Medical Center

Tel Aviv, 69710, Israel

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 10, 2014
• Study Start: March 1, 2014
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2017
• Last Updated: December 8, 2017

Record last verified: 2017-07

Locations

HU (2); BE (2); IL (3); CR (1)