Perianal FistulaSemiflex PilotNCT06446635
Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study
A study testing Semiflex Dome Catheter System in people with Perianal Fistula and Perianal Fistula Due to Crohn's Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Rationale: Perianal fistulas are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of (chronic) wound healing problems. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Perianal Fistula, Perianal Fistula Due to Crohn's Disease, Perianal Abscess
- What is being tested?
- Semiflex Dome Catheter System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteNetherlands
- Study dates
- 14 Apr 2023to 1 Aug 2025
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Perianal abscess/sinus or (Crohn's) perianal fistula
- ≥ 18 years and < 80 years
- Written informed consent
Who cannot join
- Patients with more than 2 external perianal openings
- Rectovaginal fistula
- Life expectancy < 2 years
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Amsterdam UMC
Amsterdam
AJM Pronk, +31642665328, a.pronk@amsterdamumc.nl
About this study
Rationale: Perianal fistulas are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of (chronic) wound healing problems. A novel catheter set was developed for vacuum therapy of perianal abscesses/sinuses and fistulas: The Semiflex Dome System. This system will allow for a better and faster treatment and it will offer conformability with various fistula shapes and sizes.
Objective: With this pilot study, the investigators aim to test our novel catheter set for vacuum therapy of perianal abscesses/sinuses and fistulas for feasibility and efficacy.
Read more
Study design: The design of this prospective, multicentre study is a feasibility study.
Study population: Patients (≥ 18 years) with (Crohn's) perianal fistulas and patients with perianal abscesses/sinuses are eligible.
Intervention: A tailored (length and diameter) Semiflex dome catheter is inserted under general anaesthesia, after 6 weeks of seton drainage in patients with a perianal fistula and right away in patients with a perianal abscess/sinus. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew) and is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. After two - three days the catheter will be exchanged by a shorter catheter in the outpatient setting. The therapy is continued for a maximum of four weeks in patients with a perianal abscess/sinus and two weeks in patients with perianal fistulas.
Main study parameters/endpoints: The primary objective of the study is the feasibility of the methodology with respect to smoothness of insertion and changing the semiflex catheters, capability of proper fixation of the catheter and maintaining vacuum for more than 48 hours, and compliance to the therapy in terms of pain and discomfort. Secondary objectives are efficacy of drainage of the perianal abscess/sinus, efficacy of curing the perianal abscess/sinus in terms of complete collapse of the sinus and disappearance of induration, efficacy of management of perianal fistula in terms of clinical and radiological healing, and safety in terms of complications.
Nature and extent of the burden and risks associated with participation: The Semiflex Dome Catheter System will be placed in patients with perianal fistulas and perianal abscess/sinus who would otherwise be treated using prior-art passive drainage catheters or repurposed vacuum-assisted closure therapy sponges. There are no known additional risks stemming from the proposed therapy. The Semiflex Dome Catheter System is made entirely of medical-grade silicone certified with ISO 10993- 05 and ISO 10993-10. The catheters will be connected with a tube configured to be connected to a CE certified vacuum generating system.
Sample size: Since this is a pilot study no sample size is required. The pilot study will consist of 2 parts. In the first part, 10 patients in each study group will be included and it will be assessed per study group if the catheter meets the proof of principle. After a positive result in one or both study groups, the second part of the study will start. 10 patients in each study group will be included. The proposed treatment protocol is considered feasible if at least 70% of the Semiflex dome catheter treatment per study group meets the four primary objectives.
- Being tested
- Semiflex Dome Catheter System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semiflex Dome Catheter SystemDevice
Abces: In patients that present with a perianal abscess/sinus the semiflex dome catheter is inserted under general anesthesia. A small cut is made to drain and irrigate the septic sinus.
Fistula: Under general anesthesia the seton is removed, the internal opening is excised and the internal opening is closed with a 2-0 Vicryl cross stitch.
Both: Before surgery, the length of the tract is measured on MRI or CT. A Semiflex Catheter with the appropriate length and a diameter is selected. If during surgery appears that this is not the appropriate size, a different size catheter can be used. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew). The catheter is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. The tube will be taped on the patient. After every 2-3 days the catheter will be exchanged by a 3-6 mm shorter catheter.
| Study group | Role | What they receive |
|---|---|---|
| Patients with a perianal abscess/sinus | Experimental | Not described Receives: Device: Semiflex Dome Catheter System |
| Patients with perianal fistula | Experimental | Not described Receives: Device: Semiflex Dome Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Smoothness of insertion and exchanging of the Semiflex catheter
The doctor will determine how easy the catheter is to insert on a scale of 0-10, with 0 being very difficult and 10 being very easy. A score <5 is considered as not smooth. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Measured: 3 months
Proper fixation of the Semiflex catheter
The system is properly fixed if it has been in place for >48 hours. If the system becomes loose before 48 hours, it is considered as not properly fixed. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Measured: 48 hours
Maintaining vacuum for more than 48 hours
The system is properly vaccuum if it has been vacuum for >48 hours. If the system looses vaccuum before 48 hours, it is considered as not properly vaccuum. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Measured: 48 hours
Compliance to the therapy in terms of pain and discomfort
The patient gives a painscore after the Semiflex exchange on a scale of 0-10, with 0 being not painfull and 10 being very painfull. A score >5 is considered as too painfull. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Measured: 3 months
Secondary outcomes (3)
Efficacy of drainage of the perianal abscess/sinus
Is the Semiflex capable of draining the perianal abcess/sinus. 1 month after therapy a clinical evaluation will be done to see if the perianal abscess/ sinus is healed. Clinical closure is defined as closure of the external opening without discharge of pus on palpation. After three months a MRI is made to see if the perianal abscess/sinus is radiological healed. Radiological healing defined as complete fibrosis of the abscess/sinus on MRI.
Measured: 3 months
Efficacy of management of perianal fistula in terms of clinical and radiological healing
Is the Semiflex capable of draining the perianal fistula. 1 month after therapy a clinical evaluation will be done to see if the perianal fistula is healed. Clinical closure is defined as closure of the external opening without discharge of pus or feaces on palpation. After three months a MRI is made to see if the perianal fistula is radiological healed. Radiological healing defined as complete fibrosis of the perianal fistual.
Measured: 3 months
Safety in terms of complications
All complications related to the Semiflex treatment will be recorded during the follow-up of three months.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start14 Apr 2023
- Primary completion1 May 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willem A. Bemelman, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06446635
- Sponsor's protocol ID
- 81105
- Acronym
- Semiflex Pilot
- Status last verified
- May 2024
- First submitted
- 6 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pronk AJM, van Oostendorp JY, Han-Geurts IJM, Madelska S, Buskens CJ, Bemelman WA; Semiflex Research Group. Semiflex-assisted vacuum therapy for perianal fistulas: the Semiflex pilot study. Tech Coloproctol. 2025 Dec 8;30(1):7. doi: 10.1007/s10151-025-03240-1.
PubMed 41359090
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Semiflex Assisted Vacuum Therapy for Perianal Abscesses/Sinuses and Fistula: a Pilot Study
- ClinicalTrials.gov ID
- NCT06446635
- Acronym / sponsor ID
- Semiflex Pilot / 81105
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 1 May 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 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.
Rationale: Perianal fistulas are a common, invalidating problem for which a more effective and widely applicable treatment is necessary. Vacuum therapy has become one of the main pillars for management of a wide variety of (chronic) wound healing problems. A novel catheter set was developed for vacuum therapy of perianal abscesses/sinuses and fistulas: The Semiflex Dome System. This system will allow for a better and faster treatment and it will offer conformability with various fistula shapes and sizes.
Objective: With this pilot study, the investigators aim to test our novel catheter set for vacuum therapy of perianal abscesses/sinuses and fistulas for feasibility and efficacy.
Study design: The design of this prospective, multicentre study is a feasibility study.
Study population: Patients (≥ 18 years) with (Crohn's) perianal fistulas and patients with perianal abscesses/sinuses are eligible.
Intervention: A tailored (length and diameter) Semiflex dome catheter is inserted under general anaesthesia, after 6 weeks of seton drainage in patients with a perianal fistula and right away in patients with a perianal abscess/sinus. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew) and is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. After two - three days the catheter will be exchanged by a shorter catheter in the outpatient setting. The therapy is continued for a maximum of four weeks in patients with a perianal abscess/sinus and two weeks in patients with perianal fistulas.
Main study parameters/endpoints: The primary objective of the study is the feasibility of the methodology with respect to smoothness of insertion and changing the semiflex catheters, capability of proper fixation of the catheter and maintaining vacuum for more than 48 hours, and compliance to the therapy in terms of pain and discomfort. Secondary objectives are efficacy of drainage of the perianal abscess/sinus, efficacy of curing the perianal abscess/sinus in terms of complete collapse of the sinus and disappearance of induration, efficacy of management of perianal fistula in terms of clinical and radiological healing, and safety in terms of complications.
Nature and extent of the burden and risks associated with participation: The Semiflex Dome Catheter System will be placed in patients with perianal fistulas and perianal abscess/sinus who would otherwise be treated using prior-art passive drainage catheters or repurposed vacuum-assisted closure therapy sponges. There are no known additional risks stemming from the proposed therapy. The Semiflex Dome Catheter System is made entirely of medical-grade silicone certified with ISO 10993- 05 and ISO 10993-10. The catheters will be connected with a tube configured to be connected to a CE certified vacuum generating system.
Sample size: Since this is a pilot study no sample size is required. The pilot study will consist of 2 parts. In the first part, 10 patients in each study group will be included and it will be assessed per study group if the catheter meets the proof of principle. After a positive result in one or both study groups, the second part of the study will start. 10 patients in each study group will be included. The proposed treatment protocol is considered feasible if at least 70% of the Semiflex dome catheter treatment per study group meets the four primary objectives.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with a perianal abscess/sinus | Experimental | Device: Semiflex Dome Catheter System |
| Patients with perianal fistula | Experimental | Device: Semiflex Dome Catheter System |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Perianal abscess/sinus or (Crohn's) perianal fistula
- ≥ 18 years and < 80 years
- Written informed consent
Key exclusion criteria (4 listed)
- Patients with more than 2 external perianal openings
- Rectovaginal fistula
- Life expectancy < 2 years
- Dementia or altered mental status that would prohibit the understanding and giving of informed consent
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 |
|---|---|---|
| Semiflex Dome Catheter SystemAbces: In patients that present with a perianal abscess/sinus the semiflex dome catheter is inserted under general anesthesia. A small cut is made to drain and irrigate the septic sinus. Fistula: Under general anesthesia the seton is removed, the internal opening is excised and the internal opening is closed with a 2-0 Vicryl cross stitch. Both: Before surgery, the length of the tract is measured on MRI or CT. A Semiflex Catheter with the appropriate length and a diameter is selected. If during surgery appears that this is not the appropriate size, a different size catheter can be used. The catheter is fixed on a Renasys Adhesive gel patch (Smith and Nephew). The catheter is connected with a tubing system to a vacuum pomp with an average vacuum pressure of 80 cm H2O. The tube will be taped on the patient. After every 2-3 days the catheter will be exchanged by a 3-6 mm shorter catheter. | Device | Patients with a perianal abscess/sinus, Patients with perianal fistula |
Primary outcome
Smoothness of insertion and exchanging of the Semiflex catheter
Time frame: 3 months
The doctor will determine how easy the catheter is to insert on a scale of 0-10, with 0 being very difficult and 10 being very easy. A score <5 is considered as not smooth. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Proper fixation of the Semiflex catheter
Time frame: 48 hours
The system is properly fixed if it has been in place for >48 hours. If the system becomes loose before 48 hours, it is considered as not properly fixed. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Maintaining vacuum for more than 48 hours
Time frame: 48 hours
The system is properly vaccuum if it has been vacuum for >48 hours. If the system looses vaccuum before 48 hours, it is considered as not properly vaccuum. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
Compliance to the therapy in terms of pain and discomfort
Time frame: 3 months
The patient gives a painscore after the Semiflex exchange on a scale of 0-10, with 0 being not painfull and 10 being very painfull. A score >5 is considered as too painfull. This will be scored individually and if all primary outcome measures are met, the treatment is considered successful in this participant.
3 secondary outcomes
Efficacy of drainage of the perianal abscess/sinus
Time frame: 3 months
Efficacy of management of perianal fistula in terms of clinical and radiological healing
Time frame: 3 months
Safety in terms of complications
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Derived from this study: PubMed 41359090Pronk AJM, van Oostendorp JY, Han-Geurts IJM, Madelska S, Buskens CJ, Bemelman WA; Semiflex Research Group. Semiflex-assisted vacuum therapy for perianal fistulas: the Semiflex pilot study. Tech Coloproctol. 2025 Dec 8;30(1):7. doi: 10.1007/s10151-025-03240-1.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Semiflex Dome Catheter System in people with Perianal Fistula and Perianal Fistula Due to Crohn's Disease, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 inclusion and 4 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 6 Jun 2024. 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 Netherlands. 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 AJM Pronk (+31642665328, a.pronk@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Smoothness of insertion and exchanging of the Semiflex catheter (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06446635, which also lists 1 linked publication.
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 6 Jun 2024.