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Navicam as a Triage Tool in the Management of Patients With Acute Upper Gastrointestinal Bleeding

NCT04197843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2022-05-10

No results posted yet for this study

Summary

Acute upper gastrointestinal bleeding(AUGIB) is a common emergency. The NaviCam (ANKON) is a miniaturised wireless endoscope in a single use capsule. It can be remotely controlled with the patient in a magnetic console.. In patients with AUGIB, NaviCam has been compared to conventional esophago-gastro-duodenoscopy (EGD) in their diagnostic yields. NaviCam has been shown to detect more lesions including those in the small bowel. There are therefore several theoretical advantages to the use of NaviCam in the management of patients with AUGIB.An initial NaviCam examination allows triaging of patients. Those with low risk lesions can be discharged without EGD and hospital admission. These represent substantial reduction in resource utilisation. In the diagnosis of small bowel lesions, the yield from a video capsule examination is higher closer to the time of index bleed.

The primary objective of the study is to determine the diagnostic yield of NaviCam in patients who present with overt signs of AUGIB. In addition, the investigators aim to determine if NaviCam examinations can reduce hospital resource utilisation and compare the use of NaviCam as a triage tool to the use of risk scores such as the Glasgow Blatchford Score (GBS). The investigators hypothesize that early NaviCam examination can allow safe discharge of more patients when compared to GBS.

Conditions

  • GastroIntestinal Bleeding

Interventions

DEVICE

NaviCam (ANKON)

The NaviCam (ANKON) is a miniaturised wireless endoscope in a single use capsule. It can be remotely controlled with the patient in a magnetic console. The operator to the magnetic-driven NaviCam sits in a computer workstation and manipulates the capsule suspended in a waterfilled stomach. After careful examination of the stomach, the capsule is then allowed to passed through the pylorus into duodenum and small bowel. The patient wears harness with small bowel imaging capabilities.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • James Lau · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-21
Primary Completion
2021-07-30
Completion
2021-07-30

Countries

  • China
  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04197843 on ClinicalTrials.gov