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

Ovesco Endoscopy AG30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

Interventions

HemoPill acuteDIAGNOSTIC_TEST

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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. 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: at time of study inclusion, 1 day