Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy

Colon Cancer Clinical Trial

Official title:

Assessing the Safety and Performance of the Single Use Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy: a Monocentric Post-market Observational Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03306966
• Other study ID #: ST-02
• Status: Withdrawn
• Start date: May 1, 2018
• Est. completion date: January 30, 2021

Study information

• Verified date: March 2018
• Source: Duomed
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2021
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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.

Related Conditions & MeSH terms

• Colon Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Duomed

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Number of adverse device effects.	Determination of the sharpness of the blade and occurrence of disruption of the staple line.	3 to 4 weeks follow-up
Secondary	Number of adverse device effects.	Determination of the sharpness of the blade and occurrence of disruption of the staple line.	3 months follow-up
Secondary	Number of adverse device effects.	Determination of the sharpness of the blade and occurrence of disruption of the staple line.	6 months follow-up
Secondary	Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.		3 to 4 weeks follow-up
Secondary	Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.		3 months follow-up
Secondary	Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.		6 months follow-up
Secondary	Number of patients with colectomy related re-interventions.		3 to 4 weeks follow-up
Secondary	Number of patients with colectomy related re-interventions.		3 months follow-up
Secondary	Number of patients with colectomy related re-interventions.		6 months follow-up