Rectovaginal FistulaPhase 2PRS-RVFNCT06798935
Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas
A Phase 2 study testing autologous platelet-rich stroma in people with Rectovaginal Fistula and Anovaginal Fistula, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Is the addition of platelet-rich stroma (PRS) injection, a form of autologous call therapy, to surgical treatment for rectovaginal fistula feasible and safe? The primary endpoints of this study are feasibility and safety until 12 months after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Rectovaginal Fistula, Anovaginal Fistula
- What is being tested?
- autologous platelet-rich stroma
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Jan 2019to 4 Sep 2024
- Phase
- Phase 2
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients presenting with significant symptoms of a rectovaginal fistula (RVF)
- RVF confirmed on imaging or with a high suspicion based on imaging findings (magnetic resonance imaging [MRI] and/or endoanal ultrasound [EUS])
Who cannot join
- Patients with active proctitis
- Patients with the presence of associated (not properly drained)) pelvic abscess
- Patients with immune suppressed status
- Patients with hematological disorders
- Patients with any oncological event in the five years prior to study
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Ijsselland Hospital
Capelle aan den IJssel, South Holland
About this study
Is the addition of platelet-rich stroma (PRS) injection, a form of autologous call therapy, to surgical treatment for rectovaginal fistula feasible and safe? The primary endpoints of this study are feasibility and safety until 12 months after surgery. Secondary endpoints include rates of clinical and radiological closure, recurrence rates after clinical or radiological closure and unplanned re-interventions within 12-month post-surgery.
- Conditions
- Rectovaginal Fistula, Anovaginal Fistula
- Being tested
- autologous platelet-rich stroma
- Keywords
- rectovaginal fistula, anovaginal fistula, platelet-rich stroma, stromal vascular fraction, platelet-rich plasma, autologous, cell therapy
- Medical subject headings
- Rectovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous platelet-rich stromaProcedure or surgery
Autologous platelet-rich stroma, which is the combined product of stromal vascular fraction and platelet-rich plasma
| Study group | Role | What they receive |
|---|---|---|
| Additional PRS-injection | Experimental | Patients suffering from rectovaginal fistula's underwent rectovaginal fistula surgery with an additional injection of autologous PRS Receives: Procedure: autologous platelet-rich stroma |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patietns with feasible PRS injection
Feasibility was assessed by the ability to successfully obtain SVF and PRP and to inject the combined product (i.e. PRS) during the procedure.
Measured: 1 day (day of surgery)
Secondary outcomes (5)
Number of patients with safe PRS injection
Safety was assessed by documenting the number of (serious) adverse events related to PRS injection within 30 days postoperatively. In addition, we report on number of serious fistula-related emergency room (ER) visits and number of readmissions within 30 days postoperatively.
Measured: 30 days postoperatively
Number of patients with clinical closure
closure of the vaginal fistula opening without complaints of discharge at physical examination
Measured: 12 months
Number of re-interventions
) the need for unplanned re-interventions due to residual clinical and/or radiological fistulizing disease or recurrent disease
Measured: 12 months
Number of patients with radiological healing
radiological healing or radiological improvement, based on available MRI reports
Measured: 12 months
Number of patients with recurrence
the reopening of the vaginal fistula opening after clinical closure and/or radiological healing
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start11 Jan 2019
- Primary completion4 Sep 2024
- Study completion4 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Rectovaginal FistulaStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective cohort study
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- IJsselland Hospital
- Responsible party
- Principal investigator, Anne S. Nieuwstraten, Erasmus Medical Center
- Investigators
- Oddeke van Ruler, GI- surgeon, MD, PhD, Principal investigator, IJsselland Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06798935
- Sponsor's protocol ID
- MEC-2019-0038
- Acronym
- PRS-RVF
- Status last verified
- Jan 2025
- First submitted
- 18 Jan 2025
- Last updated
- 29 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Deijl W, Arkenbosch J, van Ruler O, van der Woude CJ, Stevens HPJD, de Graaf E, Schouten R. Autologous Platelet-Rich Stroma in Complex Perianal Fistulas. Dis Colon Rectum. 2020 Jun;63(6):860-861. doi: 10.1097/DCR.0000000000001546. No abstract available.
PubMed 32384409Schouten WR, Arkenbosch JHC, van der Woude CJ, de Vries AC, Stevens HP, Fuhler GM, Dwarkasing RS, van Ruler O, de Graaf EJR. Efficacy and safety of autologous adipose-derived stromal vascular fraction enriched with platelet-rich plasma in flap repair of transsphincteric cryptoglandular fistulas. Tech Coloproctol. 2021 Dec;25(12):1301-1309. doi: 10.1007/s10151-021-02524-6. Epub 2021 Oct 4.
PubMed 34606026Arkenbosch JHC, van Ruler O, Dwarkasing RS, Fuhler GM, Schouten WR, van Oud-Alblas MB, de Graaf EJR, de Vries AC, van der Woude CJ. Stromal vascular fraction with platelet-rich plasma injection during surgery is feasible and safe in treatment-refractory perianal fistulising Crohn's disease: A pilot study. Aliment Pharmacol Ther. 2023 Apr;57(7):783-791. doi: 10.1111/apt.17347. Epub 2022 Dec 26.
PubMed 36571818
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Safety of Additional Injection of Autologous Platelet-rich Stroma to Surgical Treatment of Rectovaginal Fistulas
- ClinicalTrials.gov ID
- NCT06798935
- Acronym / sponsor ID
- PRS-RVF / MEC-2019-0038
- Conditions
- Rectovaginal Fistula, Anovaginal Fistula
- Keywords
- rectovaginal fistula, anovaginal fistula, platelet-rich stroma, stromal vascular fraction, platelet-rich plasma, autologous, cell therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- IJsselland Hospital
- Study start
- 11 Jan 2019 (actual)
- Primary completion
- 4 Sep 2024 (actual)
- Study completion
- 4 Sep 2024 (actual)
- First posted
- 29 Jan 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.
Is the addition of platelet-rich stroma (PRS) injection, a form of autologous call therapy, to surgical treatment for rectovaginal fistula feasible and safe? The primary endpoints of this study are feasibility and safety until 12 months after surgery. Secondary endpoints include rates of clinical and radiological closure, recurrence rates after clinical or radiological closure and unplanned re-interventions within 12-month post-surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| Additional PRS-injection | Experimental | Procedure: autologous platelet-rich stromaPatients suffering from rectovaginal fistula's underwent rectovaginal fistula surgery with an additional injection of autologous PRS |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- patients presenting with significant symptoms of a rectovaginal fistula (RVF)
- RVF confirmed on imaging or with a high suspicion based on imaging findings (magnetic resonance imaging [MRI] and/or endoanal ultrasound [EUS])
Key exclusion criteria (5 listed)
- Patients with active proctitis
- Patients with the presence of associated (not properly drained)) pelvic abscess
- Patients with immune suppressed status
- Patients with hematological disorders
- Patients with any oncological event in the five years prior to study
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 |
|---|---|---|
| autologous platelet-rich stromaAutologous platelet-rich stroma, which is the combined product of stromal vascular fraction and platelet-rich plasma | Procedure or surgery | Additional PRS-injection |
Primary outcome
Number of patietns with feasible PRS injection
Time frame: 1 day (day of surgery)
Feasibility was assessed by the ability to successfully obtain SVF and PRP and to inject the combined product (i.e. PRS) during the procedure.
5 secondary outcomes
Number of patients with safe PRS injection
Time frame: 30 days postoperatively
Number of patients with clinical closure
Time frame: 12 months
Number of re-interventions
Time frame: 12 months
Number of patients with radiological healing
Time frame: 12 months
Number of patients with recurrence
Time frame: 12 months
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 29 Jan 2025.
- Background: PubMed 32384409Deijl W, Arkenbosch J, van Ruler O, van der Woude CJ, Stevens HPJD, de Graaf E, Schouten R. Autologous Platelet-Rich Stroma in Complex Perianal Fistulas. Dis Colon Rectum. 2020 Jun;63(6):860-861. doi: 10.1097/DCR.0000000000001546. No abstract available.
- Background: PubMed 34606026Schouten WR, Arkenbosch JHC, van der Woude CJ, de Vries AC, Stevens HP, Fuhler GM, Dwarkasing RS, van Ruler O, de Graaf EJR. Efficacy and safety of autologous adipose-derived stromal vascular fraction enriched with platelet-rich plasma in flap repair of transsphincteric cryptoglandular fistulas. Tech Coloproctol. 2021 Dec;25(12):1301-1309. doi: 10.1007/s10151-021-02524-6. Epub 2021 Oct 4.
- Background: PubMed 36571818Arkenbosch JHC, van Ruler O, Dwarkasing RS, Fuhler GM, Schouten WR, van Oud-Alblas MB, de Graaf EJR, de Vries AC, van der Woude CJ. Stromal vascular fraction with platelet-rich plasma injection during surgery is feasible and safe in treatment-refractory perianal fistulising Crohn's disease: A pilot study. Aliment Pharmacol Ther. 2023 Apr;57(7):783-791. doi: 10.1111/apt.17347. Epub 2022 Dec 26.
- 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.
Oddeke van Ruler, GI- surgeon, MD, PhD principal investigator
IJsselland Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing autologous platelet-rich stroma in people with Rectovaginal Fistula and Anovaginal Fistula, run by Erasmus Medical Center 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 2 inclusion and 5 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 29 Jan 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 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Number of patietns with feasible PRS injection (time frame: 1 day (day of surgery)). 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 NCT06798935, which also lists 3 linked publications.
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 29 Jan 2025.