Motorized Multi Angulation Endoscopy Trial
- 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
Scheduled ESD/EMR/Polypectomy in the gastric body or at the gastro-oesophageal junction (GE-junction).
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
Name Time Method Safety (adverse events)<br>Effectiveness (procedural success / en bloc resection)<br>
- Secondary Outcome Measures
Name Time Method Efficiency (procedural time)<br>User satisfaction (system usability scale, interview)