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

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

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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).

Description

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).

Eligibility

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.

Study details
    UGI Bleed

NCT06409182

Chinese University of Hong Kong

14 May 2024

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