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Completed

NCT Number: NCT06409182

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

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).

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Key information

Conditions

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital

Hong Kong

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HemoPill

Device

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.

Primary outcomes

  1. Area under the ROC curve

    Time frame: duration of study, 2 hours

    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.

Secondary outcomes

  1. Sensitivity

    Time frame: duration of study, 2 hours

    Sensitivity of Hemopill

  2. Specificity

    Time frame: duration of study, 2 hours

    Specificity of Hemopill

  3. Positive predictive value

    Time frame: duration of study, 2 hours

    Positive predictive value of Hemopill

  4. Negative predictive value

    Time frame: duration of study, 2 hours

    Negative predicitive value of Hemopill

  5. Technical success rate

    Time frame: duration of study, 2 hours

    Technical success rate of Hemopill

  6. Adverse event rate

    Time frame: duration of study, 2 hours

    Adverse event rate of Hemopill

  7. Time to a positive HI signal

    Time frame: duration of study, 2 hours

    Time to a positive HI signal of Hemopill

  8. Time to OGD from Hemopill capsule examination

    Time frame: duration of study, 2 hours

    Time to OGD from Hemopill capsule examination

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study title

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

Acronym: HemoPill

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 10, 2024
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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