Colon CancerNCT03306966
Assessing the Safety and Performance of the Endoscopic Linear Cutter Stapler and Reloads (Frankenman) in Colectomy
An observational study of Colon Cancer, run by Duomed.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Endoscopic Linear Cutter Stapler and Reloads (Frankenman)
- Type of treatment
- Medical device
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2018to 30 Jan 2021
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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
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.
- Conditions
- Colon Cancer
- Being tested
- Endoscopic Linear Cutter Stapler and Reloads (Frankenman)
- Keywords
- Ascending colon
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic Linear Cutter Stapler and Reloads (Frankenman)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Colon cancer patients | Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy. Receives: Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with adverse events related to the index-procedure.
Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
Measured: 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.
Measured: 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.
Measured: 6 months follow-up
Secondary outcomes (9)
Number of adverse device effects.
Determination of the sharpness of the blade and occurrence of disruption of the staple line.
Measured: 3 to 4 weeks follow-up
Number of adverse device effects.
Determination of the sharpness of the blade and occurrence of disruption of the staple line.
Measured: 3 months follow-up
Number of adverse device effects.
Determination of the sharpness of the blade and occurrence of disruption of the staple line.
Measured: 6 months follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
Measured: 3 to 4 weeks follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
Measured: 3 months follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
Measured: 6 months follow-up
Number of patients with colectomy related re-interventions.
Measured: 3 to 4 weeks follow-up
Number of patients with colectomy related re-interventions.
Measured: 3 months follow-up
Number of patients with colectomy related re-interventions.
Measured: 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2017
- Study start1 May 2018 (estimated)
- Primary completion1 May 2020 (estimated)
- Study completion30 Jan 2021 (estimated)
Why it stopped: Design modification
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Duomed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kurt Van Der Speeten, Dr, Principal investigator, ZOL, Genk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306966
- Sponsor's protocol ID
- ST-02
- Status last verified
- Mar 2018
- First submitted
- 6 Oct 2017
- Last updated
- 1 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03306966
- Acronym / sponsor ID
- ST-02
- Conditions
- Colon Cancer
- Keywords
- Ascending colon
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Design modification
- Enrolment
- 0 participants (actual)
- Lead sponsor
- DuomedIndustry (pharma, biotech, devices)
- Study start
- 1 May 2018 (estimated)
- Primary completion
- 1 May 2020 (estimated)
- Study completion
- 30 Jan 2021 (estimated)
- First posted
- 11 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Colon cancer patients | – | Device: Endoscopic Linear Cutter Stapler and Reloads (Frankenman)Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with colon cancer (ascending colon) eligible for laparoscopic or open segmental colectomy.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Colon cancer patients |
Primary outcome
Number of patients with adverse events related to the index-procedure.
Time frame: 3 to 4 weeks follow-up
Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
Number of patients with adverse events related to the index-procedure.
Time frame: 3 months follow-up
Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
Number of patients with adverse events related to the index-procedure.
Time frame: 6 months follow-up
Determination of peri- and postoperative anastomotic leaks and intra-intestinal/intra-abdominal bleeding.
9 secondary outcomes
Number of adverse device effects.
Time frame: 3 to 4 weeks follow-up
Number of adverse device effects.
Time frame: 3 months follow-up
Number of adverse device effects.
Time frame: 6 months follow-up
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
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
Time frame: 3 months follow-up
Number of patients with peri- and early/late postoperative complications related to the open and laparoscopic colectomy.
Time frame: 6 months follow-up
Number of patients with colectomy related re-interventions.
Time frame: 3 to 4 weeks follow-up
Number of patients with colectomy related re-interventions.
Time frame: 3 months follow-up
Number of patients with colectomy related re-interventions.
Time frame: 6 months follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Van Der Speeten, Dr principal investigator
ZOL, Genk
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer, run by Duomed.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with adverse events related to the index-procedure. (time frame: 3 to 4 weeks follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.