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

Not Applicable

Recruiting

• Conditions: UGI Bleed

• Registration Number: NCT06409182
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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).

Detailed 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).

Study Timeline

• Study Start: 2023-12-19
• Study First Submitted: 2024-02-01
• Status Verified: 2024-05
• Study First Submitted QC: 2024-05-08
• Last Update Submitted: 2024-05-08
• Study First Posted: 2024-05-10
• Last Update Posted: 2024-05-10
• Primary Completion: 2024-11-29
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Area under the ROC curve	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 Outcome Measures

Name	Time	Method
Negative predictive value	duration of study, 2 hours	Negative predicitive value of Hemopill
Adverse event rate	duration of study, 2 hours	Adverse event rate of Hemopill
Positive predictive value	duration of study, 2 hours	Positive predictive value of Hemopill
Technical success rate	duration of study, 2 hours	Technical success rate of Hemopill
Time to a positive HI signal	duration of study, 2 hours	Time to a positive HI signal of Hemopill
Sensitivity	duration of study, 2 hours	Sensitivity of Hemopill
Specificity	duration of study, 2 hours	Specificity of Hemopill
Time to OGD from Hemopill capsule examination	duration of study, 2 hours	Time to OGD from Hemopill capsule examination

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong