Status:
WITHDRAWN
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy
Lead Sponsor:
Duomed
Conditions:
Colon Cancer
Eligibility:
All Genders
18+ years
Brief Summary
The purpose of this observational study is to evaluate the safety and performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman used in (hemi)colectomy to remove tumor...
Eligibility Criteria
Inclusion
- Age at study entry is at least 18 years.
- Patient must sign and date the informed consent form prior to the index-procedure.
- Patient has a tumor in the ascending colon.
Exclusion
- Patient is pregnant.
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2021
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03306966
Start Date
May 1 2018
End Date
January 30 2021
Last Update
June 1 2018
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