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

NCT ID: NCT03306966

Last Updated: 2018-06-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2018-05-01

Study Completion Date

2021-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Colon cancer patients

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

Endoscopic Linear Cutter Stapler and Reloads (Frankenman)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duomed

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kurt Van Der Speeten, Dr

Role: PRINCIPAL_INVESTIGATOR

ZOL, Genk

Other Identifiers

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ST-02

Identifier Type: -

Identifier Source: org_study_id

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