Endoscopic Full Thickness Resection of Gastric Subepithel... | NCT02488746

Studies
Endoscopic Full Thickness Resection of Gastric Subepithelial Tumors (FROST)

NCT02488746

Sponsor

Kliniken Ludwigsburg-Bietigheim gGmbH

Status

Terminated

Last Update Posted

Dec 9, 2016Estimated

Enrollment

5Actual

Phase

Not provided

Conditions

Gastric Neoplasms
Gastrointestinal Stromal Tumors

Interventions

GERDX(TM)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

According to study protocol the trial was terminated because the recruitment of trial participants was insufficient.

Expanded Access Info

Start Date

Mar 2015

Primary Completion Date

Sep 2018Estimated

Completion Date

Sep 2018Estimated

First Submitted Date

Jun 26, 2015

First Submission Date that Met QC Criteria

Jun 30, 2015

First Posted Date

Jul 2, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 8, 2016

Last Update Posted Date

Dec 9, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EFTR-GERDX		Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.	Device: GERDX(TM)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GERDX(TM)	Device	Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.	EFTR-GERDX

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Rate of cases in which a complete microscopic resection of the gastric subepithelial tumor could be achieved		within one week after resection (as soon as result of pathologic analysis of resected specimen is available)
Rate of complications (bleeding, perforation)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Karel Caca, Prof. Dr.	Klinikum Ludwigsburg	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Klinikum Ludwigsburg		Ludwigsburg	Baden-Wurttemberg	71640	Germany

Condition Browse Module

MeSH Terms

ID	Term
D013274	Stomach Neoplasms
D046152	Gastrointestinal Stromal Tumors

Ancestor Terms

ID	Term
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided