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

NCT04197843 | Completed DMC

• 1 other identifier: NaviCam
• Study Type: interventional
• Target: 100
• Locations: 2 countries
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• diagnostic yield of capsule endoscopy

  diagnostic yield of capsule endoscopy in patients who present with overt signs of acute gastrointestinal bleeding

  at the time of capsule endoscopy

Secondary Outcomes (5)

• number of participants with all-cause Mortality

  30 days after navicam examination

• number of participants with Further bleeding

  within 30 days after navicam examination

• Hospital stay

  within 30 days after navicam examination

• Rating for capsule endoscopy comfort level

  immediately after navicam examination

• incidence of adverse events related with capsule endoscopy

  From the date of navicam examination until the date of capsule passing out, whichever came first, assessed up to 12 months

Study Arms (1)

NaviCam (ANKON)

EXPERIMENTAL

NaviCam (ANKON)

Device: NaviCam (ANKON)

Interventions

NaviCam (ANKON) DEVICE

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.

NaviCam (ANKON)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who present with overt signs of acute upper gastroinestinal bleeding (hematemesis or melena) and are hemodynamically stable (systolic blood pressure \> 100 mmHg and pulse less than 100 per minute).

You may not qualify if:

• patients who are below the age of 18 and above 80 years,
• patients with permanent pacemakers and other metallic implants that preclude magnetic resonance examinations
• patients who are difficult to swallow capsule (e.g pharyngeal dysfunction, poor conscious state
• patients who are at risk of capsule retention (e.g. previous gastric surgery, inflammatory bowel disease)
• patients who are unable to provide an informed consent
• patients who are in pregnancy

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (2)

Changhai Hospital, the Second Military Medical University

Shanghai, Shanghai Municipality, China

Location

Endoscopy Centre, Prince of Wales Hospital

Hong Kong, N.T., Hong Kong

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• James Lau

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 8, 2019
• First Posted: December 13, 2019
• Study Start: April 21, 2020
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: May 10, 2022

Record last verified: 2022-05

Locations

HK (1); CN (1)