Upper GI BleedingDINGNCT03176407
Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule [DING]
A study testing HemoPill acute in people with Upper GI Bleeding, run by Ovesco Endoscopy AG at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Upper GI Bleeding
- What is being tested?
- HemoPill acute
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 11 Apr 2015to 29 Feb 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Gastroenterology and Oncology, Klinikum Ludwigsburg
Ludwigsburg
About this study
Official title: 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.
Read the 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.
- Conditions
- Upper GI Bleeding
- Being tested
- HemoPill acute
- Keywords
- sensor capsule
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| HemoPill acute | Experimental | 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. Receives: Diagnostic Test: HemoPill acute |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at time of study inclusion, 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study start11 Apr 2015
- Primary completion24 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Upper GI BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- There is only one patient group. The one that swallow the sensor capsule.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ovesco Endoscopy AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Gottwald, Prof. Dr., Study director, Ovesco Endoscopy AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03176407
- Sponsor's protocol ID
- CT20-HPA-1401
- Acronym
- DING
- Status last verified
- Sep 2019
- First submitted
- 21 Apr 2017
- Last updated
- 10 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31157295
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Upper Gastrointestinal (GI) Bleeding With a Novel Bleeding Sensor Capsule: A Pilot Study [DING]
- ClinicalTrials.gov ID
- NCT03176407
- Acronym / sponsor ID
- DING / CT20-HPA-1401
- Conditions
- Upper GI Bleeding
- Keywords
- sensor capsule
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ovesco Endoscopy AGIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2015 (actual)
- Primary completion
- 24 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 5 Jun 2017 (actual)
- Results
- Posted 10 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- There is only one patient group. The one that swallow the sensor capsule.
| Arm | Type | Receives |
|---|---|---|
| HemoPill acute | Experimental | Diagnostic Test: HemoPill acuteCapsule 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (22 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HemoPill acuteCapsule 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. | Diagnostic test | HemoPill acute |
Primary outcome
Number of Participants With (Serious) Adverse Event Related to the Medical Device
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 31157295Schmidt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Gottwald, Prof. Dr. study director
Ovesco Endoscopy AG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HemoPill acute in people with Upper GI Bleeding, run by Ovesco Endoscopy AG at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With (Serious) Adverse Event Related to the Medical Device (time frame: until capsule excretion happened, an average of 10 days). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03176407, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2019.