NCT01105728

Brief Summary

Gastric subepithelial masses might harbour gastrointestinal stromal tumors, which should get resected because of their malignant potential. To minimize the associated surgical trauma endoscopic endoluminal resection is favorable. Therefore in the current study endoscopic resection of gastric subepithelial masses is investigated. Since there is a certain risk of perforation due to the procedure, perforations get closed by placement of endoscopic clips (over-the-scope-clip \[OTSC\] clips).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
Last Updated

April 24, 2012

Status Verified

April 1, 2012

Enrollment Period

1.8 years

First QC Date

April 15, 2010

Last Update Submit

April 23, 2012

Conditions

Gastric Subepitelial Mass

Keywords

Gastric subepitelial massEndoscopic full thickness resection

Outcome Measures

Primary Outcomes (1)

  • R0 Resection

    Rate of R0 resections by an endoscopic approach for resection.

    30 minutes

Secondary Outcomes (1)

  • Safety

    30 minutes

Study Arms (1)

Study arm

EXPERIMENTAL

Endoscopic resection

Procedure: Endoscopic resection

Interventions

Endoscopic resectionPROCEDURE

Endoscopic resection of the gastric subepithelial mass

Study arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Endosonographically suspicous gastric subepithelial mass \<=3 cm.

You may not qualify if:

  • American Society of Anesthesiologists (ASA) classes IV or V
  • Pregnancy
  • Bleeding disorders
  • Contraindications for endoscopy
  • Endosonographically shown large vessels in the area for resection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum rechts der Isar

Munich, Bavaria, 81675, Germany

Location

MeSH Terms

Interventions

Endoscopic Mucosal Resection

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Alexander Meining, MD

    Klinikum rechts der Isar

    PRINCIPAL INVESTIGATOR

  • Stefan von Delius, MD

    Klinikum rechts der Isar

    PRINCIPAL INVESTIGATOR

  • Hubertus Feußner, MD

    Klinikum rechts der Isar

    PRINCIPAL INVESTIGATOR

  • Dirk Wilhelm, MD

    Klinikum rechts der Isar

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2010

First Posted

April 16, 2010

Study Start

April 1, 2010

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

April 24, 2012

Record last verified: 2012-04

Locations

DE(1)