E.G.Scan* research protocol: ' Disposable, transnasal versus conventional upper gastrointestinal endoscopy: a diagnostic accuracy study in patients referred for diagnostic evaluation.*

E.G.Scan* research protocol: ' Disposable, transnasal versus conventional upper gastrointestinal endoscopy: a diagnostic accuracy study in patients referred for diagnostic evaluation.* - E.G.Scan

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON38086

Enrollment

147

Registered

2012-03-13

Start date

2012-03-29

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

upper gastrointestinal lesions

Interventions

Transnasal upper endoscopy performed with the E.G.Scan* (IntroMedic Co., Ltd., Seoul, Korea) followed by conventional upper endoscopy.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Indication for diagnostic upper endoscopy - Age older than 18 years - Written informed consent

Exclusion criteria

Exclusion criteria: - Therapeutic endoscopic intervention (e.g. polypectomy) - Reduced general condition (ASA III-IV) - Known bleeding diathesis - Conurrent anticoagulation therapy - Significant history of trauma/surgery of nose or nasal cavity - Recurrent epistaxis (> 1 episode/3month) - Changed anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach and duodenum. - Implantable pacing devices

Design outcomes

Primary

Measure	Time frame
Diagnostic accuracy of procedure as determined by sensitivity and specificity for upper GI lesions.	—

Secondary

Measure	Time frame
To determine - technical success - safety - quality of procedure (evaluated by the endoscopist) of the E.G.Scan* compared to conventional upper endoscopy in patients referred for diagnostic upper endoscopy.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)