Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
NCT ID: NCT02109991
Last Updated: 2017-12-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
60 participants
INTERVENTIONAL
2014-03-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CG-100 device
CG-100 device
Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site
Interventions
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CG-100 device
Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site
Eligibility Criteria
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Inclusion Criteria
* The patient is willing to comply with protocol-specified follow-up evaluations
* The patient signed Informed Consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Colospan Ltd.
INDUSTRY
Responsible Party
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Locations
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Ziekenhuis Oost-Limburg
Genk, , Belgium
UZ Gent
Ghent, , Belgium
KBC Zagreb
Zagreb, , Croatia
Jahn Ferenc Hospital
Budapest, , Hungary
National Institute of Oncology
Budapest, , Hungary
Soroka Medical Center
Beersheba, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Assuta Medical Center
Tel Aviv, , Israel
Countries
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Other Identifiers
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CLD-001
Identifier Type: -
Identifier Source: org_study_id