Study Stopped
Design modification
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy
1 other identifier
observational
N/A
0 countries
N/A
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 tumors and create anastomoses in patients with cancer in the ascending colon. The goal of the study will be achieved by assessing the device performance and reporting of peri- and postoperative complications in a prospectively maintained database.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2018
Typical duration for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 6, 2017
CompletedFirst Posted
Study publicly available on registry
October 11, 2017
CompletedStudy Start
First participant enrolled
May 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2021
CompletedJune 1, 2018
March 1, 2018
2 years
October 6, 2017
May 30, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Number of patients with adverse events related to the index-procedure.
Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
3 to 4 weeks follow-up
Number of patients with adverse events related to the index-procedure.
Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
3 months follow-up
Number of patients with adverse events related to the index-procedure.
Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
6 months follow-up
Secondary Outcomes (9)
Number of adverse device effects.
3 to 4 weeks follow-up
Number of adverse device effects.
3 months follow-up
Number of adverse device effects.
6 months follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
3 to 4 weeks follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
3 months follow-up
- +4 more secondary outcomes
Study Arms (1)
Colon cancer patients
Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.
Interventions
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
Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duomedlead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kurt Van Der Speeten, Dr
ZOL, Genk
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 6 Months
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 6, 2017
First Posted
October 11, 2017
Study Start
May 1, 2018
Primary Completion
May 1, 2020
Study Completion
January 30, 2021
Last Updated
June 1, 2018
Record last verified: 2018-03