Perianal FistulaPLASMANCT07810075
FiLaC and PRGF-Endoret for Multi-recurrent Cryptoglandular Perianal Fistula (PLASMA Pilot Study)
A study testing Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patients in people with Perianal Fistula, run by Complejo Hospitalario Universitario de Santiago.
Trial summary
Multi-recurrent cryptoglandular perianal fistula represents a challenging clinical problem with no established surgical solution after repeated failures. This pilot study evaluates the combination of fistula-tract laser closure (FiLaC) with perilesional injection of autologous platelet-rich growth factor… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Perianal Fistula
- What is being tested?
- Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patients
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2026to 30 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Cryptoglandular perianal fistula with at least 2 previous documented surgical failures
- Parks classification: intersphincteric or transsphincteric (low or high)
- Seton drain in situ for a minimum of 6 months at the time of surgery
- No active perianal sepsis (no purulent discharge, abscess or cellulitis)
- Single fistula tract on endoanal ultrasound (no secondary tracts)
- Identifiable internal opening on preoperative assessment
Show all 9Show fewer
- Age 18 years or older
- Platelet count 100,000/µL or above on preoperative blood test
- Signed written informed consent
Who cannot join
- Crohn's disease or ulcerative colitis
- Suprasphincteric or horseshoe fistula
- Active perianal abscess or sepsis at the time of surgery
- Secondary fistula tracts on endoanal ultrasound
- Coagulopathy or thrombocytopenia (platelet count below 100,000/µL)
- Non-suspendable anticoagulant or antiplatelet therapy
Show all 9Show fewer
- Active malignancy or severe immunosuppression
- Pregnancy
- Preoperative Wexner continence score 8 or above
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Fistula-Tract Laser Closure (FiLaC) Combined With Perilesional Autologous PRGF-Endoret Injection for Multi-Recurrent Cryptoglandular Perianal Fistula: A Prospective Single-Arm Pilot Study
Multi-recurrent cryptoglandular perianal fistula represents a challenging clinical problem with no established surgical solution after repeated failures. This pilot study evaluates the combination of fistula-tract laser closure (FiLaC) with perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret) in 25 patients with a long-standing seton and no active sepsis. The primary outcome is clinical cure at 12 months. This study will provide preliminary safety and efficacy data to inform the design of a future randomised trial
Read the detailed description
Background
Perianal fistula is a benign but recurrent condition that causes significant morbidity. A subgroup of patients experiences repeated recurrence despite multiple surgical interventions, resulting in progressive fibrosis of the perianal tissue and increasing risk of sphincter damage with each reoperation. No sphincter-preserving technique consistently achieves cure after multiple surgical failures.
Fistula-tract laser closure (FiLaC) uses a radially emitting diode laser probe to achieve thermal ablation of the fistula tract epithelium. Its principal demonstrated advantage is an exceptional continence safety profile, with no cases of continence deterioration reported in large published series. However, failure rates exceed 40%, leaving a substantial proportion of patients without a definitive solution.
Platelet-rich growth factor (PRGF-Endoret; BTI Biotechnology Institute, Vitoria, Spain) is a fully autologous biological product obtained from the patient's own peripheral blood by low-speed centrifugation, free of leucocytes and exogenous activators. It releases a sustained supply of tissue repair growth factors that promote neoangiogenesis, fibroblast proliferation, and extracellular matrix remodelling. Prior studies combining platelet-rich plasma with surgical techniques for perianal fistula have reported improved clinical healing rates compared to surgery alone. The specific combination of FiLaC laser ablation with perilesional PRGF injection has not been previously evaluated.
Rationale The biological rationale for the PLASMA procedure is synergistic. Laser ablation removes the fistula tract epithelium and creates a receptive tissue bed. Immediate perilesional PRGF injection provides the growth factors required to accelerate healing and reduce the chronic inflammation that drives recurrence in multi-operated fistulas. Mandatory closure of the internal opening eliminates the high-pressure intestinal entry point that perpetuates the fistula. Selection of patients with a seton in situ for at least 6 months without active sepsis ensures a quiescent tissue microenvironment at the time of treatment.
Procedure All procedures are performed by a single surgeon under spinal anaesthesia as ambulatory day surgery. The PLASMA procedure consists of four sequential steps in a single operative session: (1) seton removal; (2) fistula tract laser ablation using a 1000-µm radially emitting FiLaC probe connected to a Leonardo Dual diode laser (1470 nm, 12 W, continuous mode, 1 mm/s withdrawal speed); (3) mandatory direct primary suture closure of the internal opening (Vicryl 2/0) in all patients; (4) perilesional injection of 7 ml of activated autologous PRGF-Endoret around the fistula tract and closure site using a 23-gauge needle under direct vision.
PRGF-Endoret is prepared on the day of surgery from 36 ml of peripheral venous blood collected in four sodium citrate tubes, centrifuged at 580 rpm for 8 minutes. The leucocyte-free platelet-rich fraction is activated with autologous calcium chloride solution immediately before injection. PRGF-Endoret has been authorised as a Sustancia de Origen Humano (SoHo) for use in this study by the Organizacion Nacional de Trasplantes (ONT) of Spain.
Statistical approach This is a descriptive pilot study. The primary endpoint will be expressed as a proportion with exact 95% confidence interval. Continence and quality of life scores will be compared between baseline and follow-up timepoints using the Wilcoxon signed-rank test for paired samples. Factors associated with clinical cure will be explored by exploratory post hoc univariate analysis. No multivariate analysis is planned. All results are hypothesis-generating and will not be interpreted as confirmatory evidence. Analyses will be performed in Python 3.12
- Conditions
- Perianal Fistula
- Being tested
- Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patients
- Keywords
- FiLaC, Fistula-tract laser closure, Platelet-rich plasma, PRGF-Endoret, Sphincter-preserving surgery, Laser surgery, Pilot study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patientsProcedure or surgery
Perilesional injection of 7 ml of autologous platelet-rich growth factor (PRGF-Endoret; BTI Biotechnology Institute, Vitoria, Spain), prepared from 36 ml of peripheral venous blood collected in four 9-ml sodium citrate tubes, centrifuged at 580 rpm for 8 minutes. The platelet-rich fraction, free of leucocytes and erythrocytes, is activated with autologous calcium chloride solution (0.05 ml of CaCl₂ 10% per ml of PRGF) immediately before injection and administered perilesionally around the fistula tract and internal opening closure site using a 23-gauge needle under direct vision.
| Study group | Role | What they receive |
|---|---|---|
| PLASMA Procedure | Experimental | Single ambulatory procedure under spinal anaesthesia: seton removal, FiLaC laser ablation (1470 nm, 12 W, 1 mm/s), direct primary suture closure of internal opening (Vicryl 2/0), perilesional injection of 7 ml autologous PRGF-Endoret. Intervention. Receives: Procedure: Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure: Clinical cure at 12 months
Complete closure of the external opening without spontaneous or compression-induced drainage on clinical examination
Measured: 12 months after the procedure
Secondary outcomes (5)
Incidence of Postoperative Complications Classified by Clavien-Dindo Grade [Safety]
Any postoperative complication within 30 days classified by Clavien-Dindo system:
Grade I = minor deviation requiring no treatment; Grade II = pharmacological treatment; Grade III = surgical/endoscopic/radiological intervention; Grade IV = organ dysfunction; Grade V = death). Proportion with Grade III or above reported separately.
Measured: 30 days after the procedure
Clinical cure at 6 months
Complete closure of the external opening without spontaneous or compression-induced drainage on clinical examination at 6 months after the procedure.
Measured: 6 months
Change in Faecal Continence Assessed by Wexner Continence Grading Scale
Wexner Continence Grading Scale (range 0-20; 0 = perfect continence, 20 = complete incontinence; lower scores indicate better continence). Change from baseline to each timepoint reported.
Measured: Baseline (preoperative), 3, 6, and 12 months after the procedure
Postoperative Pain Assessed by Visual Analogue Scale
Visual Analogue Scale for pain (range 0-10 cm; 0 = no pain, 10 = worst imaginable pain; lower scores indicate less pain)..
Measured: 24 hours, 48 hours, 7 days, and 1 month after the procedure
Fistula recurrence | 12 months • New surgical intervention
Reopening of a previously healed external orifice with drainage after documented clinical cure at any prior follow-up visit.
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 posted9 Sep 2026
- Study start1 Oct 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Perianal 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group interventional study in which all enrolled patients receive the same combined procedure (the PLASMA procedure) in a single operative session. There is no comparator arm, no randomisation, and no masking. The study follows a sequential enrolment design: consecutive eligible patients are included until the target sample of 25 is reached. The PLASMA procedure integrates two established techniques applied sequentially in the same surgical act: (1) fistula-tract laser closure (FiLaC), a sphincter-preserving ablation technique using a 1000-µm radially emitting diode laser probe (1470 nm, 12 W, continuous mode, withdrawal speed 1 mm/s); and (2) perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret, 7 ml, activated with autologous calcium chloride). Internal opening closure by direct primary suture is performed in all patients prior to PRGF injection, as a mandatory protocolised step.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Complejo Hospitalario Universitario de Santiago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fernando Fernández López, MD PhD, Complejo Hospitalario Universitario de Santiago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07810075
- Sponsor's protocol ID
- PLASMA-2026-V1
- Acronym
- PLASMA
- Status last verified
- Aug 2026
- First submitted
- 28 Aug 2026
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared publicly. Data are pseudonymised and stored under applicable Spanish and European data protection legislation (GDPR / Ley Orgánica 3/2018). Anonymised aggregate data supporting the published findings may be available upon reasonable request to the corresponding author, subject to ethics committee approval.
Publications
VanderWeele TJ, Ding P. Sensitivity Analysis in Observational Research: Introducing the E-Value. Ann Intern Med. 2017 Aug 15;167(4):268-274. doi: 10.7326/M16-2607. Epub 2017 Jul 11.
PubMed 28693043Cricri M, Miele A, Tropeano FP, Zoretti A, De Palma GD, Luglio G. A novel sphincter-sparing procedure for seton removal in complex perianal fistulas: the FiLaFlap technique. Tech Coloproctol. 2025 Dec 24;30(1):25. doi: 10.1007/s10151-025-03271-8.
PubMed 41441911Cao D, Wang X, Zhang Y, Qian K, Yang N, Zhu M, Li Y, Wu G, Cui Z. Total fistula volume predicts surgical outcomes in complex perianal fistulizing Crohn's disease following fistula-tract laser closure: a single-center retrospective study. Tech Coloproctol. 2025 Feb 17;29(1):70. doi: 10.1007/s10151-024-03094-z.
PubMed 39961900Adegbola SO, Sahnan K, Tozer P, Warusavitarne J. Emerging Data on Fistula Laser Closure (FiLaC) for the Treatment of Perianal Fistulas; Patient Selection and Outcomes. Clin Exp Gastroenterol. 2021 Dec 6;14:467-475. doi: 10.2147/CEG.S269464. eCollection 2021.
PubMed 34908858Frountzas M, Stergios K, Nikolaou C, Bellos I, Schizas D, Linardoutsos D, Kontzoglou K, Vaos G, Williams AB, Toutouzas K. Could FiLaC be effective in the treatment of anal fistulas? A systematic review of observational studies and proportional meta-analysis. Colorectal Dis. 2020 Dec;22(12):1874-1884. doi: 10.1111/codi.15148. Epub 2020 Jun 18.
PubMed 32445614Elfeki H, Shalaby M, Emile SH, Sakr A, Mikael M, Lundby L. A systematic review and meta-analysis of the safety and efficacy of fistula laser closure. Tech Coloproctol. 2020 Apr;24(4):265-274. doi: 10.1007/s10151-020-02165-1. Epub 2020 Feb 17.
PubMed 32065306Fuschillo G, Pata F, D'Ambrosio M, Selvaggi L, Pescatori M, Selvaggi F, Pellino G. Failure rates and complications of four sphincter-sparing techniques for the treatment of fistula-in-ano: a systematic review and network meta-analysis. Tech Coloproctol. 2025 May 20;29(1):116. doi: 10.1007/s10151-025-03152-0.
PubMed 40392371
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistula-Tract Laser Closure (FiLaC) Combined With Perilesional Autologous PRGF-Endoret Injection for Multi-Recurrent Cryptoglandular Perianal Fistula: A Prospective Single-Arm Pilot Study
- ClinicalTrials.gov ID
- NCT07810075
- Acronym / sponsor ID
- PLASMA / PLASMA-2026-V1
- Conditions
- Perianal Fistula
- Keywords
- FiLaC, Fistula-tract laser closure, Platelet-rich plasma, PRGF-Endoret, Sphincter-preserving surgery, Laser surgery, Pilot study
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Complejo Hospitalario Universitario de SantiagoUniversity, hospital or other
- Study start
- 1 Oct 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 9 Sep 2026 (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.
Multi-recurrent cryptoglandular perianal fistula represents a challenging clinical problem with no established surgical solution after repeated failures. This pilot study evaluates the combination of fistula-tract laser closure (FiLaC) with perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret) in 25 patients with a long-standing seton and no active sepsis. The primary outcome is clinical cure at 12 months. This study will provide preliminary safety and efficacy data to inform the design of a future randomised trial
Detailed description
Background
Perianal fistula is a benign but recurrent condition that causes significant morbidity. A subgroup of patients experiences repeated recurrence despite multiple surgical interventions, resulting in progressive fibrosis of the perianal tissue and increasing risk of sphincter damage with each reoperation. No sphincter-preserving technique consistently achieves cure after multiple surgical failures.
Fistula-tract laser closure (FiLaC) uses a radially emitting diode laser probe to achieve thermal ablation of the fistula tract epithelium. Its principal demonstrated advantage is an exceptional continence safety profile, with no cases of continence deterioration reported in large published series. However, failure rates exceed 40%, leaving a substantial proportion of patients without a definitive solution.
Platelet-rich growth factor (PRGF-Endoret; BTI Biotechnology Institute, Vitoria, Spain) is a fully autologous biological product obtained from the patient's own peripheral blood by low-speed centrifugation, free of leucocytes and exogenous activators. It releases a sustained supply of tissue repair growth factors that promote neoangiogenesis, fibroblast proliferation, and extracellular matrix remodelling. Prior studies combining platelet-rich plasma with surgical techniques for perianal fistula have reported improved clinical healing rates compared to surgery alone. The specific combination of FiLaC laser ablation with perilesional PRGF injection has not been previously evaluated.
Rationale The biological rationale for the PLASMA procedure is synergistic. Laser ablation removes the fistula tract epithelium and creates a receptive tissue bed. Immediate perilesional PRGF injection provides the growth factors required to accelerate healing and reduce the chronic inflammation that drives recurrence in multi-operated fistulas. Mandatory closure of the internal opening eliminates the high-pressure intestinal entry point that perpetuates the fistula. Selection of patients with a seton in situ for at least 6 months without active sepsis ensures a quiescent tissue microenvironment at the time of treatment.
Procedure All procedures are performed by a single surgeon under spinal anaesthesia as ambulatory day surgery. The PLASMA procedure consists of four sequential steps in a single operative session: (1) seton removal; (2) fistula tract laser ablation using a 1000-µm radially emitting FiLaC probe connected to a Leonardo Dual diode laser (1470 nm, 12 W, continuous mode, 1 mm/s withdrawal speed); (3) mandatory direct primary suture closure of the internal opening (Vicryl 2/0) in all patients; (4) perilesional injection of 7 ml of activated autologous PRGF-Endoret around the fistula tract and closure site using a 23-gauge needle under direct vision.
PRGF-Endoret is prepared on the day of surgery from 36 ml of peripheral venous blood collected in four sodium citrate tubes, centrifuged at 580 rpm for 8 minutes. The leucocyte-free platelet-rich fraction is activated with autologous calcium chloride solution immediately before injection. PRGF-Endoret has been authorised as a Sustancia de Origen Humano (SoHo) for use in this study by the Organizacion Nacional de Trasplantes (ONT) of Spain.
Statistical approach This is a descriptive pilot study. The primary endpoint will be expressed as a proportion with exact 95% confidence interval. Continence and quality of life scores will be compared between baseline and follow-up timepoints using the Wilcoxon signed-rank test for paired samples. Factors associated with clinical cure will be explored by exploratory post hoc univariate analysis. No multivariate analysis is planned. All results are hypothesis-generating and will not be interpreted as confirmatory evidence. Analyses will be performed in Python 3.12
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group interventional study in which all enrolled patients receive the same combined procedure (the PLASMA procedure) in a single operative session. There is no comparator arm, no randomisation, and no masking. The study follows a sequential enrolment design: consecutive eligible patients are included until the target sample of 25 is reached. The PLASMA procedure integrates two established techniques applied sequentially in the same surgical act: (1) fistula-tract laser closure (FiLaC), a sphincter-preserving ablation technique using a 1000-µm radially emitting diode laser probe (1470 nm, 12 W, continuous mode, withdrawal speed 1 mm/s); and (2) perilesional injection of autologous platelet-rich growth factor (PRGF-Endoret, 7 ml, activated with autologous calcium chloride). Internal opening closure by direct primary suture is performed in all patients prior to PRGF injection, as a mandatory protocolised step.
| Arm | Type | Receives |
|---|---|---|
| PLASMA Procedure | Experimental | Procedure: Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patientsSingle ambulatory procedure under spinal anaesthesia: seton removal, FiLaC laser ablation (1470 nm, 12 W, 1 mm/s), direct primary suture closure of internal opening (Vicryl 2/0), perilesional injection of 7 ml autologous PRGF-Endoret. Intervention. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Cryptoglandular perianal fistula with at least 2 previous documented surgical failures
- Parks classification: intersphincteric or transsphincteric (low or high)
- Seton drain in situ for a minimum of 6 months at the time of surgery
- No active perianal sepsis (no purulent discharge, abscess or cellulitis)
- Single fistula tract on endoanal ultrasound (no secondary tracts)
Key exclusion criteria (9 listed)
- Crohn's disease or ulcerative colitis
- Suprasphincteric or horseshoe fistula
- Active perianal abscess or sepsis at the time of surgery
- Secondary fistula tracts on endoanal ultrasound
- Coagulopathy or thrombocytopenia (platelet count below 100,000/µL)
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 |
|---|---|---|
| Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patientsPerilesional injection of 7 ml of autologous platelet-rich growth factor (PRGF-Endoret; BTI Biotechnology Institute, Vitoria, Spain), prepared from 36 ml of peripheral venous blood collected in four 9-ml sodium citrate tubes, centrifuged at 580 rpm for 8 minutes. The platelet-rich fraction, free of leucocytes and erythrocytes, is activated with autologous calcium chloride solution (0.05 ml of CaCl₂ 10% per ml of PRGF) immediately before injection and administered perilesionally around the fistula tract and internal opening closure site using a 23-gauge needle under direct vision. | Procedure or surgery | PLASMA Procedure |
Primary outcome
Measure: Clinical cure at 12 months
Time frame: 12 months after the procedure
Complete closure of the external opening without spontaneous or compression-induced drainage on clinical examination
5 secondary outcomes
Incidence of Postoperative Complications Classified by Clavien-Dindo Grade [Safety]
Time frame: 30 days after the procedure
Clinical cure at 6 months
Time frame: 6 months
Change in Faecal Continence Assessed by Wexner Continence Grading Scale
Time frame: Baseline (preoperative), 3, 6, and 12 months after the procedure
Postoperative Pain Assessed by Visual Analogue Scale
Time frame: 24 hours, 48 hours, 7 days, and 1 month after the procedure
Fistula recurrence | 12 months • New surgical intervention
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 28693043VanderWeele TJ, Ding P. Sensitivity Analysis in Observational Research: Introducing the E-Value. Ann Intern Med. 2017 Aug 15;167(4):268-274. doi: 10.7326/M16-2607. Epub 2017 Jul 11.
- Background: PubMed 41441911Cricri M, Miele A, Tropeano FP, Zoretti A, De Palma GD, Luglio G. A novel sphincter-sparing procedure for seton removal in complex perianal fistulas: the FiLaFlap technique. Tech Coloproctol. 2025 Dec 24;30(1):25. doi: 10.1007/s10151-025-03271-8.
- Background: PubMed 39961900Cao D, Wang X, Zhang Y, Qian K, Yang N, Zhu M, Li Y, Wu G, Cui Z. Total fistula volume predicts surgical outcomes in complex perianal fistulizing Crohn's disease following fistula-tract laser closure: a single-center retrospective study. Tech Coloproctol. 2025 Feb 17;29(1):70. doi: 10.1007/s10151-024-03094-z.
- Background: PubMed 34908858Adegbola SO, Sahnan K, Tozer P, Warusavitarne J. Emerging Data on Fistula Laser Closure (FiLaC) for the Treatment of Perianal Fistulas; Patient Selection and Outcomes. Clin Exp Gastroenterol. 2021 Dec 6;14:467-475. doi: 10.2147/CEG.S269464. eCollection 2021.
- Background: PubMed 32445614Frountzas M, Stergios K, Nikolaou C, Bellos I, Schizas D, Linardoutsos D, Kontzoglou K, Vaos G, Williams AB, Toutouzas K. Could FiLaC be effective in the treatment of anal fistulas? A systematic review of observational studies and proportional meta-analysis. Colorectal Dis. 2020 Dec;22(12):1874-1884. doi: 10.1111/codi.15148. Epub 2020 Jun 18.
- Background: PubMed 32065306Elfeki H, Shalaby M, Emile SH, Sakr A, Mikael M, Lundby L. A systematic review and meta-analysis of the safety and efficacy of fistula laser closure. Tech Coloproctol. 2020 Apr;24(4):265-274. doi: 10.1007/s10151-020-02165-1. Epub 2020 Feb 17.
- Background: PubMed 40392371Fuschillo G, Pata F, D'Ambrosio M, Selvaggi L, Pescatori M, Selvaggi F, Pellino G. Failure rates and complications of four sphincter-sparing techniques for the treatment of fistula-in-ano: a systematic review and network meta-analysis. Tech Coloproctol. 2025 May 20;29(1):116. doi: 10.1007/s10151-025-03152-0.
- Individual participant dataSharing planned: No. Individual participant data will not be shared publicly. Data are pseudonymised and stored under applicable Spanish and European data protection legislation (GDPR / Ley Orgánica 3/2018). Anonymised aggregate data supporting the published findings may be available upon reasonable request to the corresponding author, subject to ethics committee approval.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Laser ablation of fistula tract using 1000-µm radial fibre (Biolitec, 1470 nm, 12 W, continuous, 1 mm/s withdrawal). Internal opening closed with Vicryl 2/0 suture in all patients in people with Perianal Fistula, run by Complejo Hospitalario Universitario de Santiago.
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 9 inclusion and 9 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: opening soon, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fernando Fernández López, MD PhD (+34981951358, fernando.fernandez@usc.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure: Clinical cure at 12 months (time frame: 12 months after the procedure). 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 NCT07810075, which also lists 7 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 9 Sep 2026.