Upper Gastrointestinal BleedingNCT05631639
Detection of Upper Gastrointestinal (GI) Bleeding Using a Novel Bleeding Sensor Capsule -A Pilot Study
A study testing PillSense System in people with Upper Gastrointestinal Bleeding, run by EnteraSense Limited at 3 sites in Czechia.
Trial summary
This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- 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
- 30 participants
- Where
- 3 sitesCzechia
- Study dates
- 7 May 2021to 30 Aug 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 -80 years
- Ability to give written informed consent
- Clinical suspicion of bleeding
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
- Subject is using a pacemaker or other implantable electrical device
- Dysphagia or difficulties in swallowing pills the size of the capsule
- History of achalasia or known esophageal dysmotility
- History of gastroparesis
Show all 15Show fewer
- History of severe constipation (1 bowel movement per week or less)
- Patients who are currently pregnant or breastfeeding, or intend to become pregnant during the investigation
- Presence of psychological issues preventing participation
- Stomach bezoar
- 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
3 sites in 1 country.
Czechia3 sites
Fakultní nemocnice Olomouc (FNOL)
Olomouc
Fakultní nemocnice Ostrava (FNO)
Ostrava
Institut klinické a experimentální medicíny (IKEM),
Prague
About this study
This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB).
Read the detailed description
The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and disposable capsule and PillSense Receiver, an external real-time monitor for results display. The PillSense Capsule is a non-invasive, single use device designed to detect blood in the stomach and wirelessly transmit the data to the external PillSense Receiver. The receiver is a handheld device which displays real-time information gathered from the capsule and clearly displays results, "Blood Detected" or "No Blood Detected".
All enrolled participants were admitted for suspected UGIB and were required to ingest a PillSense Capsule followed by esophagogastroduodenoscopy (EGD) within 1 hour of PillSense Capsule administration. All Patients underwent standard endoscopy following PillSense Capsule evaluation and results were compared with the PillSense System result, i.e., "Blood Detected" or "No Blood Detected".
The study was also designed to confirm transit of the PillSense Capsule through the GI tract and patient tolerability of the PillSense Capsule.
- 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 PillSense capsule is a diagnostic capsule equipped with a sensor for in vivo detection of liquid blood and a paired PillSense receiver for result display.
| Study group | Role | What they receive |
|---|---|---|
| PillSense System | Experimental | The device is composed of an orally ingested sensor capsule and a wireless handheld receiver for real-time display of sensor data. The capsule contains a measuring slot for blood entry. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract. Receives: Device: PillSense System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Device feasibility
Ability of PillSense Capsule to detect the presence or absence of blood and send the results to the PillSense receiver
Measured: within 30 minutes
Secondary outcomes (3)
Device sensitivity
Subjects with positive findings for blood based on PillSense and EGD
Measured: within 2 hours
Device Specificity
Subjects with negative findings for blood based on PillSense and EGD
Measured: within 2 hours
Safety
Number of patients that developed device-related adverse event (etc. retention, aspiration or bowel obstruction)
Measured: up to 3 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 start7 May 2021
- Primary completion30 Jun 2021
- Study completion30 Aug 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
- 30 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
- NCT05631639
- Sponsor's protocol ID
- CIP-019-01
- 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
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 -A Pilot Study
- ClinicalTrials.gov ID
- NCT05631639
- Acronym / sponsor ID
- CIP-019-01
- Conditions
- Upper Gastrointestinal Bleeding
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- EnteraSense LimitedIndustry (pharma, biotech, devices)
- Study start
- 7 May 2021 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Aug 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.
This is a multi-center, prospective, non-randomized, open-label, exploratory clinical investigation performed to evaluate safety and effectiveness of the PillSense System when used for detection of blood in the stomach of patients suspected to have an Upper Gastrointestinal Bleed (UGIB).
Detailed description
The PillSense System consists of the PillSense Capsule, an atraumatic, ingestible, and disposable capsule and PillSense Receiver, an external real-time monitor for results display. The PillSense Capsule is a non-invasive, single use device designed to detect blood in the stomach and wirelessly transmit the data to the external PillSense Receiver. The receiver is a handheld device which displays real-time information gathered from the capsule and clearly displays results, "Blood Detected" or "No Blood Detected".
All enrolled participants were admitted for suspected UGIB and were required to ingest a PillSense Capsule followed by esophagogastroduodenoscopy (EGD) within 1 hour of PillSense Capsule administration. All Patients underwent standard endoscopy following PillSense Capsule evaluation and results were compared with the PillSense System result, i.e., "Blood Detected" or "No Blood Detected".
The study was also designed to confirm transit of the PillSense Capsule through the GI tract and patient tolerability of the PillSense Capsule.
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 SystemThe device is composed of an orally ingested sensor capsule and a wireless handheld receiver for real-time display of sensor data. The capsule contains a measuring slot for blood entry. The sensor capsule is used for diagnosis in patients with suspected acute bleeding in the upper gastrointestinal tract. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 -80 years
- Ability to give written informed consent
- Clinical suspicion of bleeding
Key exclusion criteria (15 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
- Subject is using a pacemaker or other implantable electrical 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 PillSense capsule is a diagnostic capsule equipped with a sensor for in vivo detection of liquid blood and a paired PillSense receiver for result display. | Device | PillSense System |
Primary outcome
Device feasibility
Time frame: within 30 minutes
Ability of PillSense Capsule to detect the presence or absence of blood and send the results to the PillSense receiver
3 secondary outcomes
Device sensitivity
Time frame: within 2 hours
Device Specificity
Time frame: within 2 hours
Safety
Time frame: up to 3 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.
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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.
3 sites 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 3 sites 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 3 inclusion and 15 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 3 sites 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 feasibility (time frame: within 30 minutes). 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.