Upper Gastrointestinal BleedingNCT04472364
HemoPill Acute ® in Suspected Nonvariceal Upper Gastrointestinal Bleeding
A study testing HemoPill Acute ® in people with Upper Gastrointestinal Bleeding, run by Wuerzburg University Hospital at 4 sites in Germany.
Trial summary
The study examines, whether the use of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal bleeding can identify cases in which endoscopy can be delayed to 48-96 hours without risk to the patient. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- HemoPill Acute ®
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 4 sitesGermany
- Study dates
- 8 Oct 2020to 8 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Emergency presentation with clinical suspicion of non-variceal upper GI bleeding (e.g. haematin vomiting, melena, etc.)
- hemodynamic stable patient (heart rate <100 / min, Blood pressure sys ≥ 100mmHg)
- Emergency endoscopy indicated (modified Glasgow-Blatchford-Score ≥ 2 points)
- Administration of proton pump inhibitors possible (no allergy known)
- Good communication (without translator) with the study doctor and fulfill all requirements of the study
- Written consent after detailed information about the study
Who cannot join
- Hemodynamically unstable patients (HF> 100 / min, RR <100mmHg despite fluid administration) with indication for endoscopy within 12 hours
- Indication for endoscopy within 12 hours recommended by endoscopy call service
- Clinical suspicion of variceal bleeding of the upper GI tract (risk factors according to german guidelines: cirrhosis of the liver, splanchnic thrombosis, thrombocytopenia, known increased liver / spleen stiffness, known esophageal varices)
- Clinical suspicion of lower GI bleeding (e.g. hematochezia)
- Vomiting blood (hematemesis observed by the emergency doctor or in the clinic)
- Patients with inflammatory bowel disease (Crohn's disease or ulcerative colitis)
Show all 16Show fewer
- Severe acute and chronic organ diseases that need treatment (e.g. kidney replacement treatment) (ASA ≥4)
- Changed anatomy of the upper GI tract (e.g. gastric resection)
- Known or suspected gastrointestinal obstructions, strictures, fistulas or known diverticula
- Dysphagia or other swallowing disorders
- Awareness restrictions that make it impossible to swallow the HemoPill Acute ® capsule on your own
- Patients with pacemakers, defibrillators, or other implantable electromedical devices
- Known allergy to parylene (capsule surface)
- Soon MRI scan planned
- Pregnancy or breastfeeding
- Mental impairment that limits the ability to meet all study requirements.
Trial locations and contacts
4 sites in 1 country.
Germany4 sites
Klinikum Friedrichshain
Berlin, 10249
Universitästklinik Freiburg
Freiburg im Breisgau, 79106
Sana Klinikum Offenbach GmbH
Offenbach, 63069
Universitätsklinik Würzburg
Würzburg, 97080
About this study
Official title: Impact of Blood Detection Capsule "HemoPill Acute ®" on the Time to Emergency Endoscopy in Case of Suspected Nonvariceal Upper Gastrointestinal Bleeding
The study examines, whether the use of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal bleeding can identify cases in which endoscopy can be delayed to 48-96 hours without risk to the patient.
Read the detailed description
Despite a variety of scoring systems (Glasgow-Blatchford-Score, etc.) timing of endoscopy in case of suspecting nonvariceal bleeding in the upper gastrointestinal tract is still challenging.
While very early endoscopy (within 12 hours) is required in some cases, European Society of Gastrointestinal Endoscopy (ESGE) - guidelines recommend performing emergency endoscopy within 24 hours in other cases. However, a recent study (Siau et al. 2019) showed that even this time window is only kept in 59% of cases. Therefore this study examines, whether the use of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal bleeding, can identify cases in which endoscopy can be delayed to 48-96 hours without risk to the patient.
In this study, after the routine administration of a proton pump inhibitor, hemodynamically stable emergency patients suspected of having non-variceal bleeding in the upper gastrointestinal tract receive a novel blood detection capsule (HemoPill Acute ®) for swallowing, whose result is available after 2 hours.
In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be performed within 12 hours.
If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed after 48 to 96 hours, with the patient being monitored in hospital until then. In these cases, if clinical bleeding occurs before the planned endoscopy, the patient will receive an unscheduled emergency endoscopy.
Further treatment is carried out according to current clinical standards. 30 days after discharge, the patients will be asked by telephone about their further clinical course and possible complications.
The study is planned to recruit 72 participants over 48 months in several centers. If this procedure is found to be safe, the HemoPill Acute ® capsule can be used to reduce the number of emergency endoscopies.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- HemoPill Acute ®
- Keywords
- Upper Gastrointestinal Bleeding, Capsule endoscopy, Emergency endoscopy
- 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 Acute ®Device
Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours.
| Study group | Role | What they receive |
|---|---|---|
| HemoPill | Experimental | All participants will receive the blood detection capsule HemoPill Acute ®. Receives: Device: HemoPill Acute ® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill.
In how many cases with a negative HaemoPill, the endoscopy interval can be extended to at least 48 hours without acute re-bleeding (confirmed in unscheduled emergency endoscopy) occurring in the meantime.
The criteria for suspected re-bleeding (leading to an unscheduled emergency endoscopy) are: Hematemesis, again melena or hematochezia after normalized stool, tachycardia (≥110 / min) or hypotension (RRsys ≤90 mm Hg) without other explanation, decrease in the Hb value ≥2 g/dl in the course without other explanation (e.g. dilution, nosebleeds ), no increase in Hb after transfusion of erythrocyte concentrate (s) (measured after 24 hours).
Measured: 48 to 96 hours after swallow the capsule
Secondary outcomes (4)
Rate of true positive HemoPill results leading to an emergency endoscopic intervention
HemoPill positive and emergency endoscopy with active bleeding / bleeding source
Measured: 12 hours after swallow the capsule
Rate of false positive HemoPill results
HemoPill positive and emergency endoscopy without active bleeding / bleeding source
Measured: 12 hours after swallow the capsule
Rate of false negative HemoPill results
HemoPill negative and clinical signs of bleeding and confirmation in unscheduled emergency endoscopy
Measured: 48 to 96 hours after swallow the capsule
The use of the HemoPill Acute ® capsule as part of emergency care is safe and technically easy.
Measurement of procedural complications
Measured: 30 Days after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2020
- Study start8 Oct 2020
- Primary completion8 Apr 2024
- Study completion8 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Gastrointestinal 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive the HemoPill Acute ® capsule. In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be performed within 12 hours. If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed after 48 to 96 hours.
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Vivantes Netzwerk für Gesundheit GmbH, University Hospital Freiburg, Sana Klinikum Offenbach
- Responsible party
- Principal investigator, Dr. med. Markus Brand, Wuerzburg University Hospital
- Investigators
- Alexander Meining, Prof. Dr., Principal investigator, Universital Hospital Würzburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04472364
- Sponsor's protocol ID
- Brand_HemoPill_07_07_2020
- Other IDs
- U1111-1254-9251
- Status last verified
- Jul 2024
- First submitted
- 10 Jul 2020
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Blood Detection Capsule "HemoPill Acute ®" on the Time to Emergency Endoscopy in Case of Suspected Nonvariceal Upper Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT04472364
- Acronym / sponsor ID
- Brand_HemoPill_07_07_2020
- Conditions
- Upper Gastrointestinal Bleeding
- Keywords
- Upper Gastrointestinal Bleeding, Capsule endoscopy, Emergency endoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- Vivantes Netzwerk für Gesundheit GmbH, University Hospital Freiburg, Sana Klinikum Offenbach
- Study start
- 8 Oct 2020 (actual)
- Primary completion
- 8 Apr 2024 (actual)
- Study completion
- 8 Apr 2024 (actual)
- First posted
- 15 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study examines, whether the use of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal bleeding can identify cases in which endoscopy can be delayed to 48-96 hours without risk to the patient.
Detailed description
Despite a variety of scoring systems (Glasgow-Blatchford-Score, etc.) timing of endoscopy in case of suspecting nonvariceal bleeding in the upper gastrointestinal tract is still challenging.
While very early endoscopy (within 12 hours) is required in some cases, European Society of Gastrointestinal Endoscopy (ESGE) - guidelines recommend performing emergency endoscopy within 24 hours in other cases. However, a recent study (Siau et al. 2019) showed that even this time window is only kept in 59% of cases. Therefore this study examines, whether the use of the HemoPill Acute ® capsule in case of suspected nonvariceal upper gastrointestinal bleeding, can identify cases in which endoscopy can be delayed to 48-96 hours without risk to the patient.
In this study, after the routine administration of a proton pump inhibitor, hemodynamically stable emergency patients suspected of having non-variceal bleeding in the upper gastrointestinal tract receive a novel blood detection capsule (HemoPill Acute ®) for swallowing, whose result is available after 2 hours.
In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be performed within 12 hours.
If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed after 48 to 96 hours, with the patient being monitored in hospital until then. In these cases, if clinical bleeding occurs before the planned endoscopy, the patient will receive an unscheduled emergency endoscopy.
Further treatment is carried out according to current clinical standards. 30 days after discharge, the patients will be asked by telephone about their further clinical course and possible complications.
The study is planned to recruit 72 participants over 48 months in several centers. If this procedure is found to be safe, the HemoPill Acute ® capsule can be used to reduce the number of emergency endoscopies.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive the HemoPill Acute ® capsule. In case of blood detection in the upper gi-tract (capsule positive), the endoscopy will be performed within 12 hours. If no blood is found in the upper GI tract (capsule negative), endoscopy will be performed after 48 to 96 hours.
| Arm | Type | Receives |
|---|---|---|
| HemoPill | Experimental | Device: HemoPill Acute ®All participants will receive the blood detection capsule HemoPill Acute ®. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Emergency presentation with clinical suspicion of non-variceal upper GI bleeding (e.g. haematin vomiting, melena, etc.)
- hemodynamic stable patient (heart rate <100 / min, Blood pressure sys ≥ 100mmHg)
- Emergency endoscopy indicated (modified Glasgow-Blatchford-Score ≥ 2 points)
- Administration of proton pump inhibitors possible (no allergy known)
- Good communication (without translator) with the study doctor and fulfill all requirements of the study
Key exclusion criteria (16 listed)
- Hemodynamically unstable patients (HF> 100 / min, RR <100mmHg despite fluid administration) with indication for endoscopy within 12 hours
- Indication for endoscopy within 12 hours recommended by endoscopy call service
- Clinical suspicion of variceal bleeding of the upper GI tract (risk factors according to german guidelines: cirrhosis of the liver, splanchnic thrombosis, thrombocytopenia, known increased liver / spleen stiffness, known esophageal varices)
- Clinical suspicion of lower GI bleeding (e.g. hematochezia)
- Vomiting blood (hematemesis observed by the emergency doctor or in the clinic)
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 Acute ®Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours. | Device | HemoPill |
Primary outcome
Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill.
Time frame: 48 to 96 hours after swallow the capsule
In how many cases with a negative HaemoPill, the endoscopy interval can be extended to at least 48 hours without acute re-bleeding (confirmed in unscheduled emergency endoscopy) occurring in the meantime. The criteria for suspected re-bleeding (leading to an unscheduled emergency endoscopy) are: Hematemesis, again melena or hematochezia after normalized stool, tachycardia (≥110 / min) or hypotension (RRsys ≤90 mm Hg) without other explanation, decrease in the Hb value ≥2 g/dl in the course without other explanation (e.g. dilution, nosebleeds ), no increase in Hb after transfusion of erythrocyte concentrate (s) (measured after 24 hours).
4 secondary outcomes
Rate of true positive HemoPill results leading to an emergency endoscopic intervention
Time frame: 12 hours after swallow the capsule
Rate of false positive HemoPill results
Time frame: 12 hours after swallow the capsule
Rate of false negative HemoPill results
Time frame: 48 to 96 hours after swallow the capsule
The use of the HemoPill Acute ® capsule as part of emergency care is safe and technically easy.
Time frame: 30 Days after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2024.
- 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.
Alexander Meining, Prof. Dr. principal investigator
Universital Hospital Würzburg
4 sites 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 Gastrointestinal Bleeding, run by Wuerzburg University Hospital at 4 sites 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 16 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 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of avoided emergency endoscopies (usually done within 24 hours) in case of negative HemoPill. (time frame: 48 to 96 hours after swallow the capsule). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jul 2024.