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

Not Applicable

Completed

Conditions: Upper GI Bleeding

Interventions: Diagnostic Test: HemoPill acute

Registration Number: NCT03176407

Lead Sponsor: Ovesco Endoscopy AG

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HemoPill acute	HemoPill acute	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With (Serious) Adverse Event Related to the Medical Device	until capsule excretion happened, an average of 10 days	In this outcome measure the safety of the sensor capsule is evaluated in relation to the patient application. 1. 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. 2. 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.
Number of Participants With Device Deficiencies	until data of the receiver is saved, an average of 2 weeks	All device deficiencies that appear in the study. In this outcome measure the safety and feasibility of the capsule is evaluated.
Number of Participants With Human Failures in Capsule Application	until capsule excretion happened, an average of 10 days	Human failures that appear during the capsule application or data readout.
Number of Participants With Sensor Capsule Ingestion Problems	at time of capsule ingestion, 1 day	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.
Number of Patients Which do Not Accept the Medical Device, Measured in Numbers	at time of study inclusion, 1 day	Patients that have acceptance problems with the sensor capsule in respect to its size, form or other reasons.