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Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

NCT ID: NCT02488746

Last Updated: 2016-12-09

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

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2018-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Neoplasms Gastrointestinal Stromal Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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EFTR-GERDX

Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.

GERDX(TM)

Intervention Type DEVICE

Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.

Interventions

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GERDX(TM)

Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kliniken Ludwigsburg-Bietigheim gGmbH

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Karel Caca, Prof. Dr.

Role: STUDY_CHAIR

Klinikum Ludwigsburg

Locations

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Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

Site Status

Countries

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Germany

Other Identifiers

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FROST

Identifier Type: -

Identifier Source: org_study_id