A Prospective Pilot Study to Evaluate the Diagnostic Performance of a Wireless Sensor Capsule in Detection of UGIB

Chinese University of Hong Kong30 enrolled

Overview

It is a single-center, prospective study, which will be conducted in a tertiary academic hospital (Prince of Wales Hospital). All subjects will undergo a paired examination of HemoPill® acute capsule and oesophago-gastro-duodenoscopy (OGD).

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

UGI Bleed

Interventions

HemopillDEVICE

HemoPill® acute capsule (Ovesco Endoscopy, Tuebingen, Germany) is a swallowable, wireless, sensor capsule designed for in vivo detection of liquid blood or hematin. The capsule has integrated optical microsensor for blood detection, by transmitting red and violet light via LEDs. It allows the detection of blood by photometric measuring method, in small volumes or in unprepared digestive tract. The dimensions of the capsules are 7.0mm x 26.3mm. The maximal examination time is 9 hours. The HemoPill® receiver is a portable receiver for displaying and storing measured values from the HemoPill® acute capsule. It allows a real-time, wireless, telemetric data transmission. Once activated, the HemoPill® acute capsule can be swallowed by patients with real-time measurement of HemoPill® Indicator (HI). An HI value in the red range suggests a positive finding - liquid blood or hematin has been detected.

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: Subjects are eligible if: * They have symptoms and signs of suspected UGIB (melena, per rectal bleeding, coffee ground vomiting, history of hematemesis); * They will undergo OGD within 24 hours; * Written consent obtained. Exclusion Criteria: Subjects will be excluded from the study if they have any of the followings: * Contraindications for OGD (e.g. respiratory failure, suspected perforation); * Contraindications for capsule endoscopy (e.g. known gastrointestinal obstruction or stricture, severe dysphagia, impaired consciousness); * Cardiac pacemaker or implanted electromedical devices; * History of gastrectomy or bowel resection; * Active ongoing fresh hematemesis; * Unstable hemodynamics despite adequate resuscitation; * Advanced comorbidities (defined as American Society of Anesthesiologists grade 4 or above); * Pregnancy.

Locations (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Outcomes

Primary Outcomes

Area under the ROC curve

The primary endpoint is the area-under-the-ROC curve (AUC) for HemoPill® capsule, which is defined by the true positive and false positive rates of HI signals.