Status:
COMPLETED
"Feasibility and Safety of the Calcium Alginate Hydrogel Sealant for the Treatment of Cryptoglandular Fistula-in-ano: Phase I/IIa Clinical Trial"
Lead Sponsor:
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
Conditions:
Anal Fistula
Eligibility:
All Genders
18+ years
Brief Summary
Background: Complex perianal fistulas pose a challenge to surgeons since the fistulous tract must be eliminated without impairing continence. Biological sealants have emerged as an effective alternati...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form
- Age ≥18 years
- Cryptoglandular PAF treated by Seton placement for at least 3 months, with a single External Fistulous Orifice and Internal Fistulous Orifice
Exclusion
- Informed Consent Form not signed or withdrawn
- Not possible to adhere to follow-up routine
- Another investigational drug in the previous 3 months
- Allergy to alginate
- Grade IV in American Society of Anesthesiologists scale
- Pregnancy
- History of radiotherapy in the perineal area
- Diagnosis or suspicion of Intestinal Blow Disease
- Immunosuppression, active neoplasia at the time of recruitment or in previous year, or positive for human immunodeficiency virus Internal Fistulous Orifice not located during the procedure
- Simple anal fistula (submucosa or low Intersphincteric Perianal Fistula, except association with Faecal Incontinence
- Anal stenosis that prevents exploration
- Undrained collections \>2 cm
- Rectovaginal fistulas
- Fistulas of non-cryptoglandular origin
Key Trial Info
Start Date :
January 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2019
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04740086
Start Date
January 1 2016
End Date
November 30 2019
Last Update
February 5 2021
Active Locations (1)
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1
Sandra Dios Barbeito
Seville, Spain, 41013