Determine the diagnostic accuracy of the E.G.Scan 2.0* compared to conventional upper endoscopy in patients referred for diagnostic upper endoscopy to evaluate esophageal disorders.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Diagnostic accuracy of the E.G.Scan 2.0 * compared to conventional upper
endoscopy in patients referred for diagnostic upper endoscopy as determined by
sensitivity and specificity for upper GI lesions
Secondary outcome
- technical success
- safety
- quality of procedure (evaluated by the endoscopist)
of the E.G.Scan 2.0 * compared to conventional upper endoscopy in patients
referred for diagnostic upper endoscopy evaluate esophageal disorders
Background summary
Upper gastrointestinal (GI) endoscopy is the procedure of choice for the
diagnosis and treatment of esophageal disorders. Since costs but also
complications of upper endoscopy are related to sedation, efforts have been
made to improve the tolerance for upper endoscopy and to reduce the need for
sedation. Small-caliber endoscopes have been developed which can be introduced
through the mouth or nose without the need for sedation. Several large studies
have been conducted with regard to tolerance, safety, feasibility and accuracy
of unsedated small-caliber transnasal upper endoscopy. Recently a new endoscopy
system, the E.G.Scan 2.0*, has been developed which is compact and is partly
disposable. For this design endoscope, there is no need for the laborious and
costly process of cleansing and desinfection, which needs to be done with a
standard endoscope. Besides, the E.G.Scan 2.0* can be used outside the
endoscopy unit, which allows upper endoscopy outside the hospital.
Study objective
Determine the diagnostic accuracy of the E.G.Scan 2.0* compared to conventional
upper endoscopy in patients referred for diagnostic upper endoscopy to evaluate
esophageal disorders.
Study design
The study consists of a small feasibility study and a fully paired diagnostic
accuracy study.
Intervention
Transnasal upper endoscopy performed with the E.G.Scan 2.0 * (IntroMedic Co.,
Ltd., Seoul, Korea) followed by
conventional upper endoscopy.
Study burden and risks
The potential benefit for patients is a better overall tolerance of the
procedure and performance of upper endoscopy outside the hospital. In addition,
direct and indirect costs associated with upper endoscopy can be saved as it
can be imagined that in the future, patients can undergo upper endoscopy in an
outpatient setting or even by a specialized general practitioner. The burden
consists of undergoing an additional upper endoscopy of the esophagus, which
takes approximately 10 minutes. Patients will be asked to contact the
coordinating investigator in case of (serious) adverse events with 14 days
after the procedure. No additional study visits are necessary. The risk
associated with participation is pain in the nasopharyngeal area,
(self-limiting) epistaxis (0% * 22.6%) or vasovagal collapse (0%- 0.3%).
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Indication for diagnostic upper endoscopy to evaluate esophageal disorders
- Age older than 18 years
- Written informed consent
Exclusion criteria
- Therapeutic endoscopic intervention
- Known bleeding diathesis
- Concurrent anticoagluation therapy
- History of trauma/surgery of nose or nasal cavity
- Recurrent epistaxis ( > 1 episode / 3 months)
- Altered anatomy of the upper gastroesophageal tract due to suergy of the esophagus
- Implantable pacing device
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL47629.041.13 |