CClinicalTrials.gg
Status unknownNCT04178707Updated Dec 13, 2022

Anal Fistula and Microdialysis - What is Yet to Learn?

An interventional study of OnZurf Probe, Senzime AB, Uppsala, Sweden in Anal Fistula, sponsored by University Hospital, Umeå. Status unknown at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-13.

Sponsored by University Hospital, Umeå · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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 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.

02

Conditions studied

  • Anal Fistula
03

In context

Rectal Fistula

189 studies on the registry are indexed under Rectal Fistula; 42 are open to participants now.

This study's planned enrollment of 20 is below the median of 68 across 130 interventional studies indexed under Rectal Fistula.

Browse Rectal Fistula studies →

Lead sponsor

University Hospital, Umeå is the lead sponsor of 6 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • over 18 years of age
  • to be able to understand and accept the terms of study

Exclusion criteria

Exclusion Criteria:

  • age under 18
  • dementia, language barrier
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Other
    Intervention

    Using microdialysis the patients inner enviorment of the anal fistula will be measured - levels of lactate, glucose and pyruvate.

    Device: OnZurf Probe, Senzime AB, Uppsala, Sweden

Interventions

  • DeviceOnZurf Probe, Senzime AB, Uppsala, Sweden

    Probe is inserted into the fistula and measurements are made of the inner environment.

06

What researchers measure

Primary outcomes

  1. measurements of glucose in anal fistula using microdialysis

    measurements of glucose in fistula using microdialysis, change in value is being assessed

    Time frame: 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

    Time frame: baseline measurement, 1 month follow up

Other outcomes

  1. measurement of lactate in anal fistula using microdialysis

    measurement of lactate in fistula using microdialysis, change in value is being assessed

    Time frame: baseline measurement, 1 month follow up

07

Study locations

1 of 1 sites recruiting
  • Umea University Hospital
    Umea, Vasterbotten 90381, Sweden
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04178707
Lead sponsor
University Hospital, Umeå
Responsible party
Karin Gustafsson (Medical Doctor, Principal Investigator, University Hospital, Umeå) — Principal investigator
First posted
Nov 26, 2019
Start date
Dec 10, 2019
Primary completion
Nov 30, 2023 (estimated)
Completion
Dec 20, 2024 (estimated)
Last update
Dec 13, 2022

Study contacts

Karin Strigard, Associate Professor
Contact
karin.strigard@umu.se
+4673 382 0772
Karin Adamo, PhD student
Contact
karin.adamo@umu.se
-46703364755
Ulf Gunnarsson, Professor
study chair · University Hospital, Umeå

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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