- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03176407
Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING] (DING)
Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule: A Pilot Study [DING]
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ludwigsburg, Germany
- Department of Gastroenterology and Oncology, Klinikum Ludwigsburg
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: DEVICE_FEASIBILITY
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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. |
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With (Serious) Adverse Event Related to the Medical Device
Time Frame: until capsule excretion happened, an average of 10 days
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In this outcome measure the safety of the sensor capsule is evaluated in relation to the patient application.
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until capsule excretion happened, an average of 10 days
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Number of Participants With Device Deficiencies
Time Frame: until data of the receiver is saved, an average of 2 weeks
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All device deficiencies that appear in the study.
In this outcome measure the safety and feasibility of the capsule is evaluated.
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until data of the receiver is saved, an average of 2 weeks
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Number of Participants With Human Failures in Capsule Application
Time Frame: until capsule excretion happened, an average of 10 days
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Human failures that appear during the capsule application or data readout.
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until capsule excretion happened, an average of 10 days
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Number of Participants With Sensor Capsule Ingestion Problems
Time Frame: at time of capsule ingestion, 1 day
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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.
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at time of capsule ingestion, 1 day
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Number of Patients Which do Not Accept the Medical Device, Measured in Numbers
Time Frame: at time of study inclusion, 1 day
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Patients that have acceptance problems with the sensor capsule in respect to its size, form or other reasons.
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at time of study inclusion, 1 day
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas Gottwald, Prof. Dr., Ovesco Endoscopy AG
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CT20-HPA-1401
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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