MicrodialysisNCT04319835
Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
A study testing OnZurf Probe in people with Microdialysis and Ischemia, run by Region Skane at 1 site in Sweden.
Trial summary
Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Microdialysis, Ischemia, Anastomotic Leakage
- What is being tested?
- OnZurf Probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSweden
- Study dates
- 25 Apr 2016to 4 Mar 2019
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients accepted for esophagectomy with Gastric Tube reconstruction in the Department
Who cannot join
- Surgical recontruction other than Gastric Tube
Trial locations and contacts
1 site in 1 country.
About this study
Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage
Read the detailed description
The purpose of the study is to evaluate Onzurf probe (microdialysis probe) as a monitoring method for the early diagnosis of complications after surgery in the gastrointestinal tract. Samples taken with Onzurf probe will be analyzed and then compared with routine clinical data on surgical procedures in gastrointesinala tract. These parameters are: Patient general condition, endoscopy, radiology and routine clinical samples (global) as CRP (C-reactive protein), white blood cells, blood gases.The patients are their own controls when the purpose is to see if you can detect early complications with Onzurf probe and also identify how many people gets complications after surgery in the gastrointestinal tract. The patients' clinical routine tests (blood tests, etc.) will serve as control samples, which then will be compared with results from sampling of Onzurf probe. No interventions will be carried out on the patient.
- Conditions
- Microdialysis, Ischemia, Anastomotic Leakage
- Being tested
- OnZurf Probe
- Medical subject headings
- Ischemia, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnZurf ProbeDevice
| Study group | Role | What they receive |
|---|---|---|
| Microdialysis catheter | Experimental | Surface Microdialysis catheter will be placed onto the surgical reconstruction after esophagectomy and will be evaluated for clinical safety and performance. The metabolic profile as measured by Microdialysis will be correlated to the clinical outcome. No interventions based on the results will be performed. Receives: Device: OnZurf Probe |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Measured: Measured with four hour intervals during the first seven postoperative days
Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Measured: Measured with four hour intervals during the first seven postoperative days
Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Measured: Measured with four hour intervals during the first seven postoperative days
Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Measured: Measured with four hour intervals during the first seven postoperative days
Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Measured: Measured with four hour intervals during the first seven postoperative days
Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Measured: Measured with four hour intervals during the first seven postoperative days
Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Measured: Measured with four hour intervals during the first seven postoperative days
Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Measured: Measured with four hour intervals during the first seven postoperative days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start25 Apr 2016
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MicrodialysisStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Senzime AB
- Responsible party
- Sponsor
- Investigators
- Jan Johansson, PhD, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319835
- Sponsor's protocol ID
- U-1506
- Status last verified
- Aug 2020
- First submitted
- 30 Mar 2016
- Last updated
- 19 Aug 2020
- 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 19 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local Metabolism of the Gastric Tube Reconstruction After Esophagectomy
- ClinicalTrials.gov ID
- NCT04319835
- Acronym / sponsor ID
- U-1506
- Conditions
- Microdialysis, Ischemia, Anastomotic Leakage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Senzime AB
- Study start
- 25 Apr 2016 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 24 Mar 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.
Postoperative surveillance of local metabolism of the surgical reconstruction after esophagectomy by means of Microdialysis. Dialysate is collected continuously for seven postoperative Days. Results analysed in a blinded fashion and related to the clinical outcome. Primary endpoint: anastomotic leakage
Detailed description
The purpose of the study is to evaluate Onzurf probe (microdialysis probe) as a monitoring method for the early diagnosis of complications after surgery in the gastrointestinal tract. Samples taken with Onzurf probe will be analyzed and then compared with routine clinical data on surgical procedures in gastrointesinala tract. These parameters are: Patient general condition, endoscopy, radiology and routine clinical samples (global) as CRP (C-reactive protein), white blood cells, blood gases.The patients are their own controls when the purpose is to see if you can detect early complications with Onzurf probe and also identify how many people gets complications after surgery in the gastrointestinal tract. The patients' clinical routine tests (blood tests, etc.) will serve as control samples, which then will be compared with results from sampling of Onzurf probe. No interventions will be carried out on the patient.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Microdialysis catheter | Experimental | Device: OnZurf ProbeSurface Microdialysis catheter will be placed onto the surgical reconstruction after esophagectomy and will be evaluated for clinical safety and performance. The metabolic profile as measured by Microdialysis will be correlated to the clinical outcome. No interventions based on the results will be performed. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients accepted for esophagectomy with Gastric Tube reconstruction in the Department
Key exclusion criteria (1 listed)
- Surgical recontruction other than Gastric Tube
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 |
|---|---|---|
| OnZurf Probe | Device | Microdialysis catheter |
Primary outcome
Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Time frame: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of lactate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Time frame: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of lactate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glucose measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Time frame: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glucose measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Time frame: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of glucose measured repeatedly (see below) to produce a metabolic profile over time
Concentration of pyruvate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Time frame: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of pyruvate measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Time frame: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of pyruvate measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glycerol measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology
Time frame: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
Concentration of glycerol measured by microdialysis in patients with a normal uncomplicated postoperative recovery
Time frame: Measured with four hour intervals during the first seven postoperative days
Concentration in millimoles / liter of glycerol measured repeatedly (see below) to produce a metabolic profile over time
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 19 Aug 2020.
Related trials for Microdialysis
RecruitingPhase 4
Antibiotic Tissue Penetration and Tissue Response in Head and Neck Infection and Reconstructive Surgery
Surgical Wound Infection, Neck Infection
Active, not recruitingPhase 1
Abemaciclib Neuropharmacokinetics of Diffuse Midline Glioma Using Intratumoral Microdialysis
Glioma
RecruitingObservational study
Tissue Penetration of Antibiotics in CriTically Ill Children
Pediatric Critical Illness, Critical Illness
Recruiting
Feasibility of Intra- and Post-operative Microdialysis During Neurosurgery for Central Nervous System Lesions
Glioma, Glioblastoma
RecruitingEarly Phase 1
Endometriosis and Microvascular Dysfunction: Role of Inflammation
Endometriosis
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.
Jan Johansson, PhD principal investigator
Region Skane
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OnZurf Probe in people with Microdialysis and Ischemia, run by Region Skane at 1 site in Sweden.
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 1 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 19 Aug 2020. 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 Sweden. 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?
Concentration of lactate measured by microdialysis in patients with anastomotic leakage as defined by endoscopy or radiology (time frame: Measured with four hour intervals during the first seven postoperative days). The study lists 8 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 19 Aug 2020.