STUDY TO DETERMINE AS EFFECTIVE AND SAFE IS THE RICH PLASMA IN GROWTH FACTORS IN THE TREATMENT OF A TYPE OF ANAL FISTULA IN COMPARISON WITH PLACEBO

Phase 1

• Conditions: Patients with anal fistula; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-001209-34-ES
• Lead Sponsor: FISEVI

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-18
• Last Update Posted: 18 June 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Signature of consent, age greater than 18 years and complex fistulas of cryptoglandular origin with a single path, and equal number of internal and external holes.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Non-resolved interposed or coexisting collections, non-localization of the internal orifice, simple fistula (submucosal / subcutaneous / low-interphosphorylated), pregnant, active or past cancer in less than 5 years, HIH, anal stricture to prevent anal fistula exploration, allergy To the sealing product used, rectovaginal fistulas, active or non-rectal inflammatory disease, inability to follow up, platelet antiplatelet therapy that can not be discontinued at least one week before surgery and one week later patients receiving Currently any investigational drug, or have received it within 3 months prior to enrollment in this clinical trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified