Phase III CLINICAL TRIAL, MULCHNTRIC, RANDOMIZED, BLIND DOUBLE INTWO PARALLEL GROUPS TO COMPARE THE EFFECTIVENESS AND SAFETY OF THE SIMPLE CLOSURE OF THE CRYPTTOGLANDULAR ANAL FISTULA WITH OR WITHOUT THE ADJUVANT ADMINISTRATION OF PLASMA RICO INGROWTH FACTORS (ENDORET® / PRGF® TECHNOLOGY), IN A PERIOD OF 48 WEEKS - PRGF IN ACF

FISEVI0 个研究点目标入组 100 人开始时间: 2017年9月18日最近更新: 2018年6月18日

适应症

试验速览

暂无简介。

•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

•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.

发起方

FISEVI