CClinicalTrials.gg
Sign In
WithdrawnNCT03306966Updated Jun 1, 2018

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

An observational study in Colon Cancer, sponsored by Duomed. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-06-01.

Sponsored by Duomed · Observational

Why this study was withdrawn
Design modification
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
0
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Colon Cancer

Browse trials for

Keywords

  • Ascending colon
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.

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

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.
04

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
0 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Groups and cohorts

  • Colon cancer patients

    Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.

    Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)

Interventions

  • DeviceEndoscopic 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.

05

What researchers measure

Primary outcomes

  1. Number of patients with adverse events related to the index-procedure.

    Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.

    Time frame: 3 to 4 weeks follow-up

  2. Number of patients with adverse events related to the index-procedure.

    Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.

    Time frame: 3 months follow-up

  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.

    Time frame: 6 months follow-up

Secondary outcomes

  1. Number of adverse device effects.

    Determination of the sharpness of the blade and occurrence of disruption of the staple line.

    Time frame: 3 to 4 weeks follow-up

  2. Number of adverse device effects.

    Determination of the sharpness of the blade and occurrence of disruption of the staple line.

    Time frame: 3 months follow-up

  3. Number of adverse device effects.

    Determination of the sharpness of the blade and occurrence of disruption of the staple line.

    Time frame: 6 months follow-up

  4. Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.

    Time frame: 3 to 4 weeks follow-up

  5. Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.

    Time frame: 3 months follow-up

  6. Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.

    Time frame: 6 months follow-up

  7. Number of patients with colectomy related re-interventions.

    Time frame: 3 to 4 weeks follow-up

  8. Number of patients with colectomy related re-interventions.

    Time frame: 3 months follow-up

  9. Number of patients with colectomy related re-interventions.

    Time frame: 6 months follow-up

06

Study locations

No study locations are listed for this record.

07

Registry details

Key details

Study ID
NCT03306966
Lead sponsor
Duomed
Responsible party
Sponsor
First posted
Oct 11, 2017
Start date
May 1, 2018 (estimated)
Primary completion
May 1, 2020 (estimated)
Completion
Jan 30, 2021 (estimated)
Last update
Jun 1, 2018

Study contacts

Kurt Van Der Speeten, Dr
principal investigator · ZOL, Genk

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Colonic Neoplasms→

Other studies from this sponsor

Duomed

Start the discussion