跳至主要内容
临床试验/EUCTR2013-002579-16-ES
EUCTR2013-002579-16-ES进行中(未招募)不适用

PHASE III CLINICAL TRIAL, single-center, randomized, double blind IN TWO GROUPS PARALLELS TO COMPARE THE EFFICACY AND SAFETY OF RICH PLASMA GROWTH FACTORS (PRGF) IN FRONT OF fibrin glue (TISSUCOL ®) FOR SEALING ANAL AND CRIPTOGLANDULAR FISTULA AFTER 48 WEEKS

C. HOSPITALARIO VIRGEN DEL ROCIO0 个研究点目标入组 104 人开始时间: 2014年11月4日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
104

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • Signed consent
  • Older than 18 years
  • Cryptoglandular anal fistulas. There may be at most 3 external orifices open and a maximum one inner hole.
  • 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 104
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Filed or coexisting undrained collections.
  • History of radiation therapy in the perineal area
  • No internal opening
  • Pregnant (IF POSSIBLE PREGNANCY PREGNANCY TEST DO)
  • immunosuppression
  • Patients with active neoplasia or neoplasia has had a less than a year.
  • Simple fistula (submucosal / subcutaneous / low intersphincteric)

研究者

发起方
C. HOSPITALARIO VIRGEN DEL ROCIO

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