Endoscopy 2025; 57(S 02): S193-S194
DOI: 10.1055/s-0045-1805481
Abstracts | ESGE Days 2025
Moderated poster
Therapeutic endoscopy in the upper GI tract 03/04/2025, 10:30 – 11:30 Poster Dome 2 (P0)

A prospective pilot study to evaluate the diagnostic performance of a wireless sensor capsule in detection of upper gastrointestinal bleeding

L H Lau
1   Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, Hong Kong
2   Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong
3   Li Ka Shing Institute of Health Sciences, The Chinese University of Hong Kong, Hong Kong, Hong Kong
,
X Xiao
2   Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong
,
F Sia
1   Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, Hong Kong
,
J Yu
1   Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, Hong Kong
,
F K Chan
2   Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong Kong, Hong Kong
1   Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, Hong Kong
,
J Y Lau
1   Institute of Digestive Disease, The Chinese University of Hong Kong, Hong Kong, Hong Kong
4   Department of Surgery, The Chinese University of Hong Kong, Hong Kong, Hong Kong
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Aims Upper gastrointestinal bleeding (UGIB) is common and potentially lethal. An accurate risk stratification is necessary to triage patients and inform clinicians for the timing of endoscopy. A wireless dual optical sensor capsule without camera (HemoPill acute; OVESCO; Germany) is designed for in-vivo detection of blood or hematin.

Methods We performed an industry-independent, prospective, single-arm pilot study. (NCT06409182) Subjects with symptoms of suspected UGIB (melaena, per rectal bleeding, coffee ground vomiting, prior haematemesis) were included. Subjects with ongoing fresh haematemesis, unstable haemodynamics, contraindications to capsule endoscopy, implanted electromedical devices, history of gastrectomy and advanced comorbidities were excluded. All subjects underwent a paired examination of HemoPill capsule and oesophago-gastro-duodenoscopy (OGD). An independent research staff instructed the subjects to swallow the capsule and connected it to the external receiver, then recorded the value and time of maximum HemoPill Indicator (HI). A positive HI signal is defined as≥0.8 in the first ten minutes and≥1.0 after ten minutes up to 2 hours. Next, subjects underwent OGD within 2 hours. All endoscopists were blinded from the HI results. The primary outcome was clinically significant UGIB, defined as the presence of active bleeding or potential bleeding source in OGD, which warranted endoscopic haemostatic treatment. A true positive case was defined as a subject having both positive HI and positive OGD examination [1] [2] [3] [4].

Results From December 2023 to April 2024, we recruited 30 eligible subjects. The mean age was 66 years old with 53.3% of male. The initial presenting symptoms were melaena, coffee ground vomiting and prior haematemesis in 76.7%, 6.7% and 16.6% of subjects respectively. Upon presentation, the mean systolic and diastolic blood pressures were 140.7 and 73.5 mmHg respectively. The mean pulse rate was 90.8 per minute. The mean haemoglobin and urea levels were 9.8 g/dL and 11.6 mmol/l respectively. The mean Glasgow Blatchford Score was 8.3 (ranging from 1-15). The average time from HemoPill to OGD examination was 61 minutes. 3 subjects (10%) had fresh blood detected during endoscopy and 7 subjects (23.3%) required endoscopic haemostasis. Using 120 minutes as the cut-off for HI measurement, there were 5 true positive and 2 false negative cases. The overall negative predictive value was 86.7% (95%CI 0.584-0.977) and the sensitivity was 71.4% (95%CI 0.303-0.949). The specificity was 56.5% (95%CI 0.349-0.761) due to false positive cases related to the presence of bile reflux.

Conclusions Our pilot data demonstrated a huge practice-changing potential for this novel, non-invasive, easy-to-use wireless sensor capsule in screening for clinically significant UGIB. The need of hospital admissions and emergent endoscopies can be reduced. A large-scale, prospective study will be conducted to evaluate the diagnostic performance of a new generation triple-sensor HemoPill capsule, which minimizes false-positive signals from bile reflux.



Publication History

Article published online:
27 March 2025

© 2025. European Society of Gastrointestinal Endoscopy. All rights reserved.

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  • References

  • 1 Brunk T, Schmidt A, Hochberger J, Wedi E, Meier B, Braun G. et al. Telemetric capsule-based upper gastrointestinal tract – blood detection – first multicentric experience. Minim Invasive Ther Allied Technol 2022; 31 (05): 704-11
    CrossrefPubMedSearch in Google Scholar
  • 2 Schmidt A, Zimmermann M, Bauder M, Kuellmer A, Caca K.. Novel telemetric sensor capsule for EGD urgency triage: a feasibility study. Endosc Int Open 2019; 7 (06): E774-81
    PubMedSearch in Google Scholar
  • 3 Schostek S, Zimmermann M, Keller J, Fode M, Melbert M, Schurr MO. et al. Volunteer Case Series of a New Telemetric Sensor for Blood Detection in the Upper Gastrointestinal Tract: The HemoPill. Dig Dis Sci 2016; 61 (10): 2956-62
    CrossrefPubMedSearch in Google Scholar
  • 4 Schostek S, Zimmermann M, Keller J, Fode M, Melbert M, Prosst RL. et al. Pre-clinical study on a telemetric gastric sensor for recognition of acute upper gastrointestinal bleeding: the “HemoPill monitor.”. Surg Endosc 2020; 34 (02): 888-98
    CrossrefPubMedSearch in Google Scholar