Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

December 8, 2016 updated by: Kliniken Ludwigsburg-Bietigheim gGmbH
Prospective observational trial. A full thickness resection of gastric subepithelial tumors is performed after application of full thickness sutures underneath the tumor with the GERDX(TM) device. Hypothesis: This endoscopic method is feasible, effective and safe.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Baden-Württemberg
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Klinikum Ludwigsburg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients in which a subepithelial gastric tumor has been detected (in our hospital, other hospitals or by transferring doctor).

Description

Inclusion Criteria:

  • presence of a subepithelial gastric tumor with signs of potential malignancy in endoscopic ultrasound
  • age 18 years or older
  • participant has given informed consent

Exclusion Criteria:

  • tumor size > 40 mm (endosonographic measurement) or large extramural tumor mass
  • signs of systemic dissemination of tumor
  • current presence of a different neoplastic disease (except after successful curative treatment without continued medication)
  • former surgery or disease of esophagus or stomach that impedes insertion of the suturing device
  • moribund patient
  • limited possibility to give informed consent (e.g. language barrier, psychiatric disease)
  • pregnancy and lactation period

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
EFTR-GERDX
Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.
Device: GERDX(TM)
Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate of cases in which a complete macroscopic en bloc resection of the gastric subepithelial tumor could be achieved
Time Frame: intraoperative
intraoperative

Secondary Outcome Measures

Outcome Measure
Time Frame
Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved
Time Frame: within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Rate of complications (bleeding, perforation)
Time Frame: 6 months after resection
6 months after resection
Duration of hospitalization
Time Frame: within one week after resection
within one week after resection
Number of participants with local or systemic recidive of tumor
Time Frame: 6 months after resection
6 months after resection
Number of participants with needs of surgical therapy or endoscopic re-resection
Time Frame: 6 months after resection
6 months after resection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

Investigators

  • Study Chair: Karel Caca, Prof. Dr., Klinikum Ludwigsburg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2015

Primary Completion (Anticipated)

September 1, 2018

Study Completion (Anticipated)

September 1, 2018

Study Registration Dates

First Submitted

June 26, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

December 9, 2016

Last Update Submitted That Met QC Criteria

December 8, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FROST

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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