Anal FistulaNCT04178707
Anal Fistula and Microdialysis - What is Yet to Learn?
A study testing OnZurf Probe, Senzime AB, Uppsala, Sweden in people with Anal Fistula, run by University Hospital, Umeå at 1 site in Sweden.
Trial summary
Anal Fistula can be a challenging condition to treat. Microdialysis has never before been used to examine the inner environment of anal fistula. This is now going to be performed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- OnZurf Probe, Senzime AB, Uppsala, Sweden
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSweden
- Study dates
- 10 Dec 2019to 20 Dec 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- to be able to understand and accept the terms of study
Who cannot join
- age under 18
- dementia, language barrier
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Umea University Hospital
Umeå, Västerbotten County, 90381
Karin Stigard, Associate Professor, +46733820772, karin.strigard@umu.se
Karin Adamo, MD, +46703364755, karin.adamo@umu.se
About this study
Official title: Intervention With Microdialysis Measurements in Anal Fistula
Anal Fistula can be a challenging condition to treat. Microdialysis has never before been used to examine the inner environment of anal fistula. This is now going to be performed.
Read the detailed description
Patients with anal fistula can have a reduced quality of life for years do to fistula complications. This condition is not well researched and more knowledge is needed to provide better care. Microdialysis has been used to study other organs of the body such as the brain, liver and GI-tract. Upcoming study is going to study the inner environment of the anal fistula in regards to lactate, pyruvate and glucose.
The study group is patients with anal fistula that with a need for seton treatment. Measurements with microdialysis will take place before operative procedure and one month after getting their seton inserted.
- Conditions
- Anal Fistula
- Being tested
- OnZurf Probe, Senzime AB, Uppsala, Sweden
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OnZurf Probe, Senzime AB, Uppsala, SwedenDevice
Probe is inserted into the fistula and measurements are made of the inner environment.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | Using microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate. Receives: Device: OnZurf Probe, Senzime AB, Uppsala, Sweden |
What is being measured
The primary outcome is the main question the study is designed to answer.
measurements of glucose in anal fistula using microdialysis
measurements of glucose in fistula using microdialysis, change in value is being assessed
Measured: baseline measurement, 1 month follow up
Secondary outcomes (1)
measurement of pyruvate in anal fistula using microdialysis
measurement of pyruvate measurements in fistula using microdialysis, change in value is being assessed
Measured: baseline measurement, 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start10 Dec 2019
- Primary completion30 Nov 2023 (estimated)
- Study completion20 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Microdialysis is used to investigate the inner enviorment of anal fistulas. The patient will be its own control with measurements at prior to intervention and after operative procedure.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Umeå
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karin Gustafsson, University Hospital, Umeå
- Investigators
- Ulf Gunnarsson, Professor, Study chair, University Hospital, Umeå
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178707
- Sponsor's protocol ID
- UMUmea
- Status last verified
- Dec 2022
- First submitted
- 25 Oct 2019
- Last updated
- 13 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention With Microdialysis Measurements in Anal Fistula
- ClinicalTrials.gov ID
- NCT04178707
- Acronym / sponsor ID
- UMUmea
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, UmeåUniversity, hospital or other
- Study start
- 10 Dec 2019 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 20 Dec 2024 (estimated)
- First posted
- 26 Nov 2019 (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.
Anal Fistula can be a challenging condition to treat. Microdialysis has never before been used to examine the inner environment of anal fistula. This is now going to be performed.
Detailed description
Patients with anal fistula can have a reduced quality of life for years do to fistula complications. This condition is not well researched and more knowledge is needed to provide better care. Microdialysis has been used to study other organs of the body such as the brain, liver and GI-tract. Upcoming study is going to study the inner environment of the anal fistula in regards to lactate, pyruvate and glucose.
The study group is patients with anal fistula that with a need for seton treatment. Measurements with microdialysis will take place before operative procedure and one month after getting their seton inserted.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Microdialysis is used to investigate the inner enviorment of anal fistulas. The patient will be its own control with measurements at prior to intervention and after operative procedure.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Device: OnZurf Probe, Senzime AB, Uppsala, SwedenUsing microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age
- to be able to understand and accept the terms of study
Key exclusion criteria (2 listed)
- age under 18
- dementia, language barrier
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, Senzime AB, Uppsala, SwedenProbe is inserted into the fistula and measurements are made of the inner environment. | Device | Intervention |
Primary outcome
measurements of glucose in anal fistula using microdialysis
Time frame: baseline measurement, 1 month follow up
measurements of glucose in fistula using microdialysis, change in value is being assessed
1 secondary outcome
measurement of pyruvate in anal fistula using microdialysis
Time frame: baseline measurement, 1 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 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.
Ulf Gunnarsson, Professor study chair
University Hospital, Umeå
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, Senzime AB, Uppsala, Sweden in people with Anal Fistula, run by University Hospital, Umeå 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 2 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: status not confirmed, as of the sponsor's last update on 13 Dec 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karin Strigard, Associate Professor (+4673 382 0772, karin.strigard@umu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
measurements of glucose in anal fistula using microdialysis (time frame: baseline measurement, 1 month follow up). 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 13 Dec 2022.