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

The Chinese University of Hong Kong

Status: Enrolling

Conditions: UGI Bleed

Treatments: Device: Hemopill

Study type: Interventional

Funder types: Other

Identifiers

NCT06409182

2023.549

Details and patient eligibility

About

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).

Full 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).

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Hemopill

Experimental group

Description:

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.

Treatment:

Device: Hemopill