PancreatitisWOPN-MONITORNCT07131917
Bedside Monitoring of Microenvironmental Changes in Infected Pancreatic Collections
A study testing Miniaturized Intracavitary Monitoring Probe in people with Pancreatitis and Walled Off Pancreatic Necrosis, run by Martin Harazim at 1 site in Czechia.
Trial summary
This pilot clinical study aims to assess the feasibility and clinical relevance of bedside monitoring of microenvironmental conditions within infected walled-off pancreatic necrosis (WOPN). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreatitis, Walled Off Pancreatic Necrosis
- What is being tested?
- Miniaturized Intracavitary Monitoring Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Nov 2025to 15 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥ 18 years
- Diagnosis of walled-off pancreatic necrosis (WOPN) confirmed by imaging (CT, MRI, or EUS)
- Clinical suspicion or confirmation of infection in WOPN (e.g., fever, elevated inflammatory markers, positive culture)
- Planned percutaneous drainage as part of standard care
- Ability to provide informed consent (or surrogate consent where applicable)
Who cannot join
- Coagulopathy not correctable prior to intervention (e.g., INR > 2.0 or platelets < 50×10⁹/L)
- Known allergy or hypersensitivity to materials used in the monitoring probe
- technical limitations precluding safe probe insertion
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Feasibility, Safety and Clinical Impact of Bedside Microenvironmental Monitoring in Infected Walled-Off Pancreatic Necrosis During Standard Percutaneous Drainage
This pilot clinical study aims to assess the feasibility and clinical relevance of bedside monitoring of microenvironmental conditions within infected walled-off pancreatic necrosis (WOPN).
WOPN is a serious complication of acute pancreatitis, often associated with infection, organ failure, and the need for drainage or surgical intervention. Although infection is a key factor in prognosis, little is known about the local chemical environment inside the infected collections.
Read more
In this study, a sterile, miniaturized probe will be temporarily introduced into the necrotic cavity during standard percutaneous drainage. The goal is to record local microenvironmental parameters (such as acidity or related values) and monitor their changes over time.
By comparing these values with clinical data (e.g., inflammatory markers, microbiology, need for surgery), the study aims to determine whether such measurements can provide additional information about infection severity and treatment response.
The study does not involve any experimental treatment. All patients will receive standard medical care, including antibiotics, imaging, and drainage according to international guidelines.
Participation is voluntary. Only patients who provide informed consent will be enrolled.
Read the detailed description
Background:
Infected walled-off pancreatic necrosis (WOPN) represents a critical complication of acute necrotizing pancreatitis. Management typically includes antibiotics and step-up interventional drainage. However, decision-making is often based on indirect systemic markers, and very little is known about the actual in situ microenvironmental conditions (e.g., pH, oxygenation, redox status) inside the necrotic cavity.
Rationale and Innovation:
The metabolic and microbiological activity within infected WOPN likely alters the local chemical environment, particularly in terms of acidity and anaerobic conditions. These changes may influence pathogen virulence, host immune response, and - importantly - the stability and efficacy of administered antibiotics. There is currently no standard method for directly monitoring these local parameters at the bedside. This pilot study explores the feasibility and potential clinical value of such monitoring.
Objective:
To determine whether bedside microenvironmental monitoring inside infected WOPN is feasible, safe, and potentially useful for clinical decision-making.
Methods:
This is a single-arm, prospective, interventional feasibility study. Patients with clinically confirmed infected WOPN undergoing standard percutaneous drainage will be offered participation. A sterile, biocompatible mini-probe (≤1.5 mm diameter) will be introduced into the collection during drainage and used to monitor selected parameters (e.g., pH) intermittently or continuously for up to 24-72 hours. The sensor will be removed safely without compromising drainage.
Data will be collected on insertion feasibility, measurement quality, patient tolerance, and any complications. Clinical parameters (CRP, PCT, SOFA score), microbiology, and clinical outcomes (resolution of infection, need for surgery, mortality) will be tracked and compared with measured values.
Outcomes:
Primary outcomes include the feasibility of safe insertion and measurement, and preliminary correlation with infection severity and clinical course. Secondary outcomes include association of monitored values with microbiology, organ dysfunction, and treatment response.
Future Direction:
If successful, this study will lay the groundwork for larger observational trials and possibly interventional studies using pH- or microenvironment-guided therapy (e.g., antibiotic selection or early intervention).
- Conditions
- Pancreatitis, Walled Off Pancreatic Necrosis
- Being tested
- Miniaturized Intracavitary Monitoring Probe
- Keywords
- pancreatitis
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miniaturized Intracavitary Monitoring ProbeDevice
A sterile, miniaturized, biocompatible monitoring probe (≤1.5 mm diameter) is temporarily introduced into the cavity of an infected walled-off pancreatic necrosis (WOPN) during standard percutaneous drainage. The device is designed to measure local microenvironmental parameters in situ, such as acidity and related indicators, without interfering with fluid evacuation. Measurements are performed intermittently or continuously for up to 72 hours and are used solely for observational purposes. This intervention is distinct from standard WOPN management, as it allows real-time assessment of local physicochemical conditions, which are not accessible through systemic biomarkers or imaging alone.
| Study group | Role | What they receive |
|---|---|---|
| Bedside Microenvironment Monitoring Arm | Experimental | Participants in this arm will undergo standard percutaneous drainage of infected walled-off pancreatic necrosis (WOPN) as per clinical indication. In addition, a sterile, biocompatible micro-monitoring probe will be temporarily introduced into the collection to measure local microenvironmental parameters. Measurements will be performed intermittently or continuously for up to 72 hours without compromising drainage function. No investigational drug or therapeutic intervention is administered. Receives: Device: Miniaturized Intracavitary Monitoring Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and Safety of Intracavitary Monitoring During Percutaneous Drainage of Infected WOPN
Successful placement, function, and removal of the miniaturized monitoring probe during standard percutaneous drainage of infected WOPN. Feasibility is defined as the ability to insert the probe without interrupting drainage, record interpretable data for at least 24 hours, and remove the device without adverse events. Safety is assessed by the absence of procedure-related complications, such as bleeding, infection exacerbation, or drainage dysfunction related to the monitoring device.
Measured: From Day 0 (drainage procedure) to Day 3 or removal of the probe, whichever occurs first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2025
- Study start1 Nov 2025 (estimated)
- Primary completion28 May 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PancreatitisStudies 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 enrolled participants undergo standard percutaneous drainage of infected WOPN. A single-arm study assesses feasibility and clinical impact of adding bedside microenvironmental monitoring using a miniaturized sensor probe temporarily inserted into the collection.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Martin Harazim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Martin Harazim, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07131917
- Sponsor's protocol ID
- WOPN-MONITOR-001
- Acronym
- WOPN-MONITOR
- Status last verified
- Aug 2025
- First submitted
- 13 Aug 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This is a single-center pilot study with a limited sample size and exploratory objectives. The decision to share individual participant data (IPD) will depend on the quality, completeness, and generalizability of the collected data, as well as institutional and ethical considerations regarding data anonymization and reuse. A data sharing plan may be developed in future phases of research if the findings support broader dissemination.
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Safety and Clinical Impact of Bedside Microenvironmental Monitoring in Infected Walled-Off Pancreatic Necrosis During Standard Percutaneous Drainage
- ClinicalTrials.gov ID
- NCT07131917
- Acronym / sponsor ID
- WOPN-MONITOR / WOPN-MONITOR-001
- Conditions
- Pancreatitis, Walled Off Pancreatic Necrosis
- Keywords
- pancreatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Martin HarazimUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 28 May 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 20 Aug 2025 (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 pilot clinical study aims to assess the feasibility and clinical relevance of bedside monitoring of microenvironmental conditions within infected walled-off pancreatic necrosis (WOPN).
WOPN is a serious complication of acute pancreatitis, often associated with infection, organ failure, and the need for drainage or surgical intervention. Although infection is a key factor in prognosis, little is known about the local chemical environment inside the infected collections.
In this study, a sterile, miniaturized probe will be temporarily introduced into the necrotic cavity during standard percutaneous drainage. The goal is to record local microenvironmental parameters (such as acidity or related values) and monitor their changes over time.
By comparing these values with clinical data (e.g., inflammatory markers, microbiology, need for surgery), the study aims to determine whether such measurements can provide additional information about infection severity and treatment response.
The study does not involve any experimental treatment. All patients will receive standard medical care, including antibiotics, imaging, and drainage according to international guidelines.
Participation is voluntary. Only patients who provide informed consent will be enrolled.
Detailed description
Background:
Infected walled-off pancreatic necrosis (WOPN) represents a critical complication of acute necrotizing pancreatitis. Management typically includes antibiotics and step-up interventional drainage. However, decision-making is often based on indirect systemic markers, and very little is known about the actual in situ microenvironmental conditions (e.g., pH, oxygenation, redox status) inside the necrotic cavity.
Rationale and Innovation:
The metabolic and microbiological activity within infected WOPN likely alters the local chemical environment, particularly in terms of acidity and anaerobic conditions. These changes may influence pathogen virulence, host immune response, and - importantly - the stability and efficacy of administered antibiotics. There is currently no standard method for directly monitoring these local parameters at the bedside. This pilot study explores the feasibility and potential clinical value of such monitoring.
Objective:
To determine whether bedside microenvironmental monitoring inside infected WOPN is feasible, safe, and potentially useful for clinical decision-making.
Methods:
This is a single-arm, prospective, interventional feasibility study. Patients with clinically confirmed infected WOPN undergoing standard percutaneous drainage will be offered participation. A sterile, biocompatible mini-probe (≤1.5 mm diameter) will be introduced into the collection during drainage and used to monitor selected parameters (e.g., pH) intermittently or continuously for up to 24-72 hours. The sensor will be removed safely without compromising drainage.
Data will be collected on insertion feasibility, measurement quality, patient tolerance, and any complications. Clinical parameters (CRP, PCT, SOFA score), microbiology, and clinical outcomes (resolution of infection, need for surgery, mortality) will be tracked and compared with measured values.
Outcomes:
Primary outcomes include the feasibility of safe insertion and measurement, and preliminary correlation with infection severity and clinical course. Secondary outcomes include association of monitored values with microbiology, organ dysfunction, and treatment response.
Future Direction:
If successful, this study will lay the groundwork for larger observational trials and possibly interventional studies using pH- or microenvironment-guided therapy (e.g., antibiotic selection or early intervention).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All enrolled participants undergo standard percutaneous drainage of infected WOPN. A single-arm study assesses feasibility and clinical impact of adding bedside microenvironmental monitoring using a miniaturized sensor probe temporarily inserted into the collection.
| Arm | Type | Receives |
|---|---|---|
| Bedside Microenvironment Monitoring Arm | Experimental | Device: Miniaturized Intracavitary Monitoring ProbeParticipants in this arm will undergo standard percutaneous drainage of infected walled-off pancreatic necrosis (WOPN) as per clinical indication. In addition, a sterile, biocompatible micro-monitoring probe will be temporarily introduced into the collection to measure local microenvironmental parameters. Measurements will be performed intermittently or continuously for up to 72 hours without compromising drainage function. No investigational drug or therapeutic intervention is administered. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years
- Diagnosis of walled-off pancreatic necrosis (WOPN) confirmed by imaging (CT, MRI, or EUS)
- Clinical suspicion or confirmation of infection in WOPN (e.g., fever, elevated inflammatory markers, positive culture)
- Planned percutaneous drainage as part of standard care
- Ability to provide informed consent (or surrogate consent where applicable)
Key exclusion criteria (3 listed)
- Coagulopathy not correctable prior to intervention (e.g., INR > 2.0 or platelets < 50×10⁹/L)
- Known allergy or hypersensitivity to materials used in the monitoring probe
- technical limitations precluding safe probe insertion
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 |
|---|---|---|
| Miniaturized Intracavitary Monitoring ProbeA sterile, miniaturized, biocompatible monitoring probe (≤1.5 mm diameter) is temporarily introduced into the cavity of an infected walled-off pancreatic necrosis (WOPN) during standard percutaneous drainage. The device is designed to measure local microenvironmental parameters in situ, such as acidity and related indicators, without interfering with fluid evacuation. Measurements are performed intermittently or continuously for up to 72 hours and are used solely for observational purposes. This intervention is distinct from standard WOPN management, as it allows real-time assessment of local physicochemical conditions, which are not accessible through systemic biomarkers or imaging alone. | Device | Bedside Microenvironment Monitoring Arm |
Primary outcome
Feasibility and Safety of Intracavitary Monitoring During Percutaneous Drainage of Infected WOPN
Time frame: From Day 0 (drainage procedure) to Day 3 or removal of the probe, whichever occurs first
Successful placement, function, and removal of the miniaturized monitoring probe during standard percutaneous drainage of infected WOPN. Feasibility is defined as the ability to insert the probe without interrupting drainage, record interpretable data for at least 24 hours, and remove the device without adverse events. Safety is assessed by the absence of procedure-related complications, such as bleeding, infection exacerbation, or drainage dysfunction related to the monitoring device.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. This is a single-center pilot study with a limited sample size and exploratory objectives. The decision to share individual participant data (IPD) will depend on the quality, completeness, and generalizability of the collected data, as well as institutional and ethical considerations regarding data anonymization and reuse. A data sharing plan may be developed in future phases of research if the findings support broader dissemination.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miniaturized Intracavitary Monitoring Probe in people with Pancreatitis and Walled Off Pancreatic Necrosis, run by Martin Harazim 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 20 Aug 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 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Martin Harazim, MD (+420 532 233 052, igek-jip@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and Safety of Intracavitary Monitoring During Percutaneous Drainage of Infected WOPN (time frame: From Day 0 (drainage procedure) to Day 3 or removal of the probe, whichever occurs first). 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 20 Aug 2025.