Clinical trial NCT03176407: Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING]
Official title: Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule: A Pilot Study [DING]
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper GI Bleeding
Keywords: sensor capsule
Lead sponsor: Ovesco Endoscopy AG
Sponsor class: INDUSTRY
First posted: 2017-06-05
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: There is only one patient group. The one that swallow the sensor capsule.
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With (Serious) Adverse Event Related to the Medical Device
timeFrame: until capsule excretion happened, an average of 10 days
measure: Number of Participants With Device Deficiencies
timeFrame: until data of the receiver is saved, an average of 2 weeks
measure: Number of Participants With Human Failures in Capsule Application
timeFrame: until capsule excretion happened, an average of 10 days
measure: Number of Participants With Sensor Capsule Ingestion Problems
timeFrame: at time of capsule ingestion, 1 day
measure: Number of Patients Which do Not Accept the Medical Device, Measured in Numbers
timeFrame: at time of study inclusion, 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Ludwigsburg
country: Germany
facility: Department of Gastroenterology and Oncology, Klinikum Ludwigsburg
Study officials:
affiliation: Ovesco Endoscopy AG
name: Thomas Gottwald, Prof. Dr.
role: STUDY_DIRECTOR
References:
citation: 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 Jun;7(6):E774-E781. doi: 10.1055/a-0880-5312. Epub 2019 May 17.