Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy
NCT ID: NCT03306966
Last Updated: 2018-06-01
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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WITHDRAWN
OBSERVATIONAL
2018-05-01
2021-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Colon cancer patients
Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.
Endoscopic Linear Cutter Stapler and Reloads (Frankenman)
The Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman received CE-mark in April 2013. It is used to staple and simultaneously divide tissue from the central line.
Interventions
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Endoscopic Linear Cutter Stapler and Reloads (Frankenman)
The Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman received CE-mark in April 2013. It is used to staple and simultaneously divide tissue from the central line.
Eligibility Criteria
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Inclusion Criteria
* Patient must sign and date the informed consent form prior to the index-procedure.
* Patient has a tumor in the ascending colon.
Exclusion Criteria
* Patient has inflammatory bowel disease (ulcerative colitis, Crohn's disease).
* Patient has symptomatic diverticulitis.
* Patient has bowel trauma.
* Patient has peritoneal carcinomatosis.
* Patient is known to be, or suspected of being unable to comply with the study protocol or proposed follow-up visits.
18 Years
ALL
No
Sponsors
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Duomed
INDUSTRY
Responsible Party
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Principal Investigators
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Kurt Van Der Speeten, Dr
Role: PRINCIPAL_INVESTIGATOR
ZOL, Genk
Other Identifiers
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ST-02
Identifier Type: -
Identifier Source: org_study_id
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