Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING]

Study Overview
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Brief Summary
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The clinical trial entitled Detection of upper gastrointestinal (GI) bleeding with a novel bleeding sensor capsule - a pilot study was carried out in a monocentric clinical trial with 30 patients. This trial aimed to determine if the capsule's sensor signals allow to deduct the patient's bleeding status in a clinical setting. The target of the explorative study was to show the feasibility and safety of the HemoPill acute and its implementation procedure as well as, the definition of measurable parameters and thresholds for blood detection. Within this clinical trial, initial clinical data on the performance of the HemoPill acute capsule were collected.

Detailed Description
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The clinical trial entitled Detection of upper gastrointestinal (GI) bleeding with a novel bleeding sensor capsule - a pilot study was carried out in a monocentric clinical trial with 30 patients as part of the final development phase of the HemoPill acute, a bleeding sensor capsule. The swallowable capsule operates with the combination of an optical sensor for blood detection positioned within a recess in the capsule surface and a radio interface for wireless transmission of sensor data to an external receiver device. The HemoPill acute capsule is used for diagnosis of patients with suspected acute upper gastrointestinal bleeding. For the study, the HemoPill acute capsule was swallowed by the patient and a special extracorporeal receiver was positioned next to the patient's body. The receiver recorded sensor signals from the ingested capsule for the next 4 hours. Patients who had swallowed a capsule underwent endoscopy within the next 12 hours. Later, both the endoscopic pictures and the endoscopy report were compared to the sensor capsule data recorded in the extracorporeal receiver. Furthermore, the excretion of each HemoPill acute capsule was monitored in accordance with the study protocol (regular check to see if sensor signal was still detectable from inside the patient's body) for a follow-up period of 10 days.

Official Title
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Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule: A Pilot Study [DING]

Conditions
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Upper GI Bleeding

Intervention / Treatment
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* Diagnostic Test: HemoPill acute


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clinical suspicion based on anamnestic statements and clinical symptom vomiting of hematin (coffee-ground-like material) hematemesis melena (anamnestic or digital rectal evidence) attentive and conscious patient written informed consent, age ≥ 18 years and ≤ 80 years Exclusion Criteria: circulatory instability (with a clear need for urgent endoscopy) cases which required urgently surgical therapy, e.g. patients previously treated endoscopically because of GI bleeding and with an urgent suspicion of recurrent bleeding, which could not be treated endoscopically because of previous findings as well as patients experiencing re-bleeding after surgery known and assumed stenosis of the GI tract, e.g. patients with fistulas, malformations and anatomical variability, insufficiencies, adhesions and previous traumas pacemakers or other implantable electrical devices difficulties in swallowing pills the size of the capsule known dysphagia (e.g. achalasia, known diverticula of the esophagus etc.) which were inoperable: patients with ASA IV or higher known and distinct retardation of the gastro-intestinal tract, induced by previous surgeries, stenosis or paralytic ileus with a diagnosed enteritis moribund patient pregnancy and breastfeeding psychological illnesses, which might impair patient cooperation (comprehension problems, informed consent impossible) stomach bezoar NSAR-induced enteropathy known allergies against Parylene (surface coating of the capsule) peptic esophagitis III an IV florid M.Crohn or known inflammation-induced strictures distinct diverticulosis or diverticulitis suspected gastrointestinal tumor disease necessity of MRI investigation heavy genetic bleeding tendency (e.g. factor VIII deficiency) esophagus varices class III obesity (BMI ≥ 40) missing informed consent age < 18 years and > 80 years

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: There is only one patient group. The one that swallow the sensor capsule.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HemoPill acute<br>Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days. | Diagnostic Test: HemoPill acute<br>* Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours. Patients undergo endoscopy within 12 hours after capsule ingestion. Afterwards, the endoscopic findings (endoscopy pictures and patient's endoscopy report) are compared to the sensor capsule data results. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With (Serious) Adverse Event Related to the Medical Device | In this outcome measure the safety of the sensor capsule is evaluated in relation to the patient application. Every malfunction, failure or characteristic change or performance of the medical device as well as each inappropriate labeling or instruction for use, which can directly or indirectly lead to death or a serious advers event that deteriorates the physical health state of a patient, user or another person. Every technical or medical reason, which are a result of the causes mentioned in No.1 due to the characteristics or performance of the medical device. | until capsule excretion happened, an average of 10 days | 
| Number of Participants With Device Deficiencies | All device deficiencies that appear in the study. In this outcome measure the safety and feasibility of the capsule is evaluated. | until data of the receiver is saved, an average of 2 weeks | 
| Number of Participants With Human Failures in Capsule Application | Human failures that appear during the capsule application or data readout. | until capsule excretion happened, an average of 10 days | 
| Number of Participants With Sensor Capsule Ingestion Problems | In this outcome measure the feasibility of the capsule is evaluated and if patients have issues on swallowing the sensor capsule in respect to it's size, form or other reasons. | at time of capsule ingestion, 1 day | 
| Number of Patients Which do Not Accept the Medical Device, Measured in Numbers | Patients that have acceptance problems with the sensor capsule in respect to its size, form or other reasons. | at time of study inclusion, 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sensor capsule