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Submucosal Tumor Removal by Endoscopic Excision Therapy

NCT04913077 · Status: SUSPENDED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2024-03-19

No results posted yet for this study

Summary

Smaller submucosal tumors (SMT) in the stomach are usually seen as an incidental finding during a gastroscopy, although current diagnostics usually do not clearly indicate what type of tumor it is. In summary, there is no good evidence for dealing with SMT. In this study, an endoscopic full-thickness resection, primarily with the FTRD device, is to be offered to all patients with gastric SMT without a confirmed histology seen in a certain period of time . Patients who do not want to take advantage of this are included in a systematic follow-up program.

The investigators hope to learn about the rate of so-called GIST tumors and other histologies, as well as the rate of change in the follow-up group.

Also, study contents will be accuracy of endosonographic imaging and puncture in comparison with resection histology, technical feasibility and histological completeness of the FTRD- based endoscopic (full-wall) resection option, complications of such a resection (secondary bleeding and dehiscences), and patient preferences with standardized information.

Conditions

  • Submucosal Tumor of Stomach

Interventions

OTHER

removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)

FTRD (Ovesco company) in tumors up to 10 mm and predominantly intraluminal growth directly by sucking into the cap, at 10-20 mm and/or intramural/extramural growth by prior circumcision and lateral preparation, so that the lesions can be better pulled into the cap. The procedure depends on the endosonographic extent of the findings. The lesions are pulled into the cap with grippers and other instruments and, if necessary, with a snare and then resected with FTRD

Sponsors & Collaborators

  • Ovesco Endoscopy AG

    collaborator INDUSTRY

  • Universitätsklinikum Hamburg-Eppendorf

    lead OTHER

Principal Investigators

  • Thomas Rösch, Prof. Dr. · Universitätsklinikum Hamburg-Eppendorf

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-10
Primary Completion
2024-11-30
Completion
2025-02-28

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04913077 on ClinicalTrials.gov