GastroIntestinal BleedingNCT06441201
Acute Gastrointestinal Bleeding Peripheral Pulse Volume Changes
An observational study of GastroIntestinal Bleeding, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GastroIntestinal Bleeding
- What is being tested?
- Pulse flowmeter
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jun 2024to 22 Sep 2025
- Phase
- Observational
- 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
- Adult, Older adult
Study population: Subjects undergoing emergent endoscopic evaluation for active gastrointestinal bleeding at Mayo Clinic, Rochester, Minnesota.
Who may be able to join
- Adults (age >18yr) undergoing emergent endoscopy for active GI bleeding.
Who cannot join
- Patients with pre-existing heart failure (ejection fraction <40%), cardiac rhythm abnormalities and peripheral vascular disease.
- Patients with underlying implanted cardiac electrical devices and spinal cord stimulators.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Pulse Volume Changes in Acute Gastrointestinal Bleeding
The purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically.
Read the detailed description
The maximum change in volume of a limb segment during the cardiac cycle - pulse volume - will be monitored non-invasively along with standard vitals in patients with a suspected gastrointestinal bleed undergoing endoscopy. Pulse volume and vitals will be collected prior to and following endoscopy up to the point of dismissal from the endoscopy unit so that the data may be correlated with the endoscopic and clinical findings.
- Conditions
- GastroIntestinal Bleeding
- Being tested
- Pulse flowmeter
- Medical subject headings
- Gastrointestinal Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulse flowmeterDiagnostic test
Measures peripheral pulse volumes by an electrode applied non-invasively to the lower extremity (left or right) at the beginning of the endoscopic evaluation for the duration of the procedure, and up to 2 hours after the completion of the procedure.
| Study group | Role | What they receive |
|---|---|---|
| Gastrointestinal Bleeding Peripheral Pulse Volume | Subject undergoing an emergency endoscopic evaluation for active gastrointestinal bleeding will have their peripheral pulse volumes monitored using a pulse flowmeter throughout the procedure and 2 hours after the procedure. Receives: Diagnostic Test: Pulse flowmeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in peripheral pulse volume with and without active bleeding
Peripheral pulse volume as measured by pulse flowmeter (uL/cm) pre and post endoscopic evaluation
Measured: Baseline, approximately 2 hours post endoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start13 Jun 2024
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroIntestinal BleedingStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jad P. AbiMansour, Mayo Clinic
- Investigators
- Andrew Storm, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441201
- Sponsor's protocol ID
- 23-005579
- Status last verified
- Dec 2025
- First submitted
- 29 May 2024
- Last updated
- 11 Dec 2025
- 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 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Pulse Volume Changes in Acute Gastrointestinal Bleeding
- ClinicalTrials.gov ID
- NCT06441201
- Acronym / sponsor ID
- 23-005579
- Conditions
- GastroIntestinal Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 13 Jun 2024 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 4 Jun 2024 (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 purpose and aim of this study are to compare changes in pulse volume to non-invasively predict active bleeding or high-risk stigmata in patients undergoing a gastrointestinal endoscopy to assess feasibility of the flow meter clinically.
Detailed description
The maximum change in volume of a limb segment during the cardiac cycle - pulse volume - will be monitored non-invasively along with standard vitals in patients with a suspected gastrointestinal bleed undergoing endoscopy. Pulse volume and vitals will be collected prior to and following endoscopy up to the point of dismissal from the endoscopy unit so that the data may be correlated with the endoscopic and clinical findings.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastrointestinal Bleeding Peripheral Pulse Volume | – | Diagnostic Test: Pulse flowmeterSubject undergoing an emergency endoscopic evaluation for active gastrointestinal bleeding will have their peripheral pulse volumes monitored using a pulse flowmeter throughout the procedure and 2 hours after the procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Subjects undergoing emergent endoscopic evaluation for active gastrointestinal bleeding at Mayo Clinic, Rochester, Minnesota.
Key inclusion criteria (1 listed)
- Adults (age >18yr) undergoing emergent endoscopy for active GI bleeding.
Key exclusion criteria (2 listed)
- Patients with pre-existing heart failure (ejection fraction <40%), cardiac rhythm abnormalities and peripheral vascular disease.
- Patients with underlying implanted cardiac electrical devices and spinal cord stimulators.
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 |
|---|---|---|
| Pulse flowmeterMeasures peripheral pulse volumes by an electrode applied non-invasively to the lower extremity (left or right) at the beginning of the endoscopic evaluation for the duration of the procedure, and up to 2 hours after the completion of the procedure. | Diagnostic test | Gastrointestinal Bleeding Peripheral Pulse Volume |
Primary outcome
Changes in peripheral pulse volume with and without active bleeding
Time frame: Baseline, approximately 2 hours post endoscopy
Peripheral pulse volume as measured by pulse flowmeter (uL/cm) pre and post endoscopic evaluation
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 11 Dec 2025.
- 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.
Andrew Storm, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of GastroIntestinal Bleeding, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 2 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 11 Dec 2025. 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 United States. 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?
Changes in peripheral pulse volume with and without active bleeding (time frame: Baseline, approximately 2 hours post endoscopy). 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 11 Dec 2025.