MedPath

Motorized Multi Angulation Endoscopy Trial

Not Applicable
Conditions
Disease in the stomach or lower part of the esophagus (early tumor)
Registration Number
DRKS00013105
Lead Sponsor
DEMCO
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete
Sex
All
Target Recruitment
30
Inclusion Criteria

Scheduled ESD/EMR/Polypectomy in the gastric body or at the gastro-oesophageal junction (GE-junction).

Exclusion Criteria

Age under 18 years
Health status ASA 4-5
Pregnancy
Metastasis
Coagulopathy (INR=2.0, Platelets < 50/nl)
Taking anti-platelet agents or anticoagulants (other than aspirin) within last 2 days
Any medical contraindication to standard upper GI endoscopy
Prior esophagectomy, prior removal of more than 1/3 of the stomach, or implantable devices in this location (cardiac pacemakers and non-abdominal implants are acceptable)
Absence of a signed informed consent

Study & Design

Study Type
interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Safety (adverse events)<br>Effectiveness (procedural success / en bloc resection)<br>
Secondary Outcome Measures
NameTimeMethod
Efficiency (procedural time)<br>User satisfaction (system usability scale, interview)
© Copyright 2025. All Rights Reserved by MedPath