Upper Gastrointestinal BleedingNCT05631652
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
A study testing PillSense System in people with Upper Gastrointestinal Bleeding, run by EnteraSense Limited at 1 site in Czechia.
Trial summary
The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Gastrointestinal Bleeding
- What is being tested?
- PillSense System
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCzechia
- Study dates
- 11 Feb 2021to 11 Mar 2021
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18 -60 years
- Ability to give written informed consent
Who cannot join
- Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure <100 mmHg,heart rate > 100 / min)
- Known current stenosis of the GI tract
- Presence of pacemaker or other implantable electronic device
- Dysphagia or difficulties in swallowing pills the size of the capsule
- History of achalasia or known esophageal dysmotility
- History of gastroparesis
Show all 16Show fewer
- History of severe constipation (1 bowel movement per week or less)
- Healthy volunteers who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
- Active psychological issues preventing participation
- Stomach bezoar
- History of severe esophagitis
- History of Crohn disease
- History of diverticulitis
- History of bowel obstruction
- Suspected gastrointestinal tumor disease
- Planned MRI investigation (MRI needed before the capsule is excreted)
Trial locations and contacts
1 site in 1 country.
About this study
The objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.
Read the detailed description
A total of 10 healthy volunteers were recruited to undergo a testing procedure. Subjects were instructed to ingest the PillSense Capsule with 100mL of water. The position of the capsule in the stomach was verified by fluoroscopy. Subjects were then asked to sequentially drink (every 5min) 2 mixtures containing 25mL of water and 25mL of their own blood obtained from a peripheral vein. The PillSense result ("blood detected" or " blood not detected") was recorded on Clinical Report Form after 5 minutes from capsule ingestion and after 5 minutes from the ingestion of both mixtures containing blood.
Subjects were followed-up for capsule passing.
- Conditions
- Upper Gastrointestinal Bleeding
- Being tested
- PillSense System
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillSense SystemDevice
The device is composed of an orally ingested PillSense capsule and a wireless handheld PillSense receiver for real-time display of sensor data. The capsule contains an optical sensor for in-vivo detection of blood. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract.
| Study group | Role | What they receive |
|---|---|---|
| PillSense System | Experimental | All subjects were asked to swallow a PillSense Capsule, followed by the ingestion of autologous blood mixed with water, to verify the ability of the PillSense System to correctly identify blood. Receives: Device: PillSense System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device ability to detect the absence of blood
Number of subjects in which PillSense capsule was able to identify the absence of blood post capsule ingestion and transmit the results to PillSense Receiver
Measured: within 30 minutes
Device ability to detect the presence of blood
Number of subjects in which PillSense Capsule was able to identify the presence of blood post ingestion of a mixture containing autologous blood and transmit the results to PillSense Receiver
Measured: within 30 minutes
Secondary outcomes (3)
Ability to ingest the capsule
Number of subjects that were able to ingest the capsule
Measured: within 30 minutes
Absence of device-related adverse event
Number of subject that were able to naturally pass the capsule.
Measured: up to 4 weeks
Absence of device-related adverse event
Number of subject that presented device-related adverse events (e.g. capsule retention, aspiration or bowel obstruction)
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start11 Feb 2021
- Primary completion11 Mar 2021
- Study completion11 Mar 2021
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- EnteraSense Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05631652
- Sponsor's protocol ID
- CIP-019-02
- Status last verified
- Nov 2022
- First submitted
- 14 Nov 2022
- Last updated
- 30 Nov 2022
- 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 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -Healthy Volunteers Study
- ClinicalTrials.gov ID
- NCT05631652
- Acronym / sponsor ID
- CIP-019-02
- Conditions
- Upper Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- EnteraSense LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Feb 2021 (actual)
- Primary completion
- 11 Mar 2021 (actual)
- Study completion
- 11 Mar 2021 (actual)
- First posted
- 30 Nov 2022 (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 objective of the investigation is to evaluate the feasibility of detecting blood in healthy volunteers after ingestion of autologous blood mixed with water.
Detailed description
A total of 10 healthy volunteers were recruited to undergo a testing procedure. Subjects were instructed to ingest the PillSense Capsule with 100mL of water. The position of the capsule in the stomach was verified by fluoroscopy. Subjects were then asked to sequentially drink (every 5min) 2 mixtures containing 25mL of water and 25mL of their own blood obtained from a peripheral vein. The PillSense result ("blood detected" or " blood not detected") was recorded on Clinical Report Form after 5 minutes from capsule ingestion and after 5 minutes from the ingestion of both mixtures containing blood.
Subjects were followed-up for capsule passing.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PillSense System | Experimental | Device: PillSense SystemAll subjects were asked to swallow a PillSense Capsule, followed by the ingestion of autologous blood mixed with water, to verify the ability of the PillSense System to correctly identify blood. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Age 18 -60 years
- Ability to give written informed consent
Key exclusion criteria (16 listed)
- Circulatory or hemodynamic instability with a clear need for urgent endoscopy or surgery (systolic blood pressure <100 mmHg,heart rate > 100 / min)
- Known current stenosis of the GI tract
- Presence of pacemaker or other implantable electronic device
- Dysphagia or difficulties in swallowing pills the size of the capsule
- History of achalasia or known esophageal dysmotility
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 |
|---|---|---|
| PillSense SystemThe device is composed of an orally ingested PillSense capsule and a wireless handheld PillSense receiver for real-time display of sensor data. The capsule contains an optical sensor for in-vivo detection of blood. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract. | Device | PillSense System |
Primary outcome
Device ability to detect the absence of blood
Time frame: within 30 minutes
Number of subjects in which PillSense capsule was able to identify the absence of blood post capsule ingestion and transmit the results to PillSense Receiver
Device ability to detect the presence of blood
Time frame: within 30 minutes
Number of subjects in which PillSense Capsule was able to identify the presence of blood post ingestion of a mixture containing autologous blood and transmit the results to PillSense Receiver
3 secondary outcomes
Ability to ingest the capsule
Time frame: within 30 minutes
Absence of device-related adverse event
Time frame: up to 4 weeks
Absence of device-related adverse event
Time frame: up to 4 weeks
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 30 Nov 2022.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillSense System in people with Upper Gastrointestinal Bleeding, run by EnteraSense Limited at 1 site in Czechia.
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 2 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 30 Nov 2022. 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 Czechia. 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?
Device ability to detect the absence of blood (time frame: within 30 minutes). The study lists 2 primary outcomes in all. 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 30 Nov 2022; AzTrials last refreshed its copy on 26 Oct 2026.