EUCTR2011-004820-37-ES进行中（未招募）不适用
Phase II, open-label clinical trial to evaluate the safety and efficacy of platelet-rich plasma and fibrin clot processed with PRGF-System tecnology in the treatment of anal fistulas in Crohn's patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
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
- •Age 18 or over / Confirmed diagnosis of Crohn's disease a year before
- •the inclusion date / Presence of perianal fistula / Identifiable internal
- •orifice / Demonstration activity of the fistulizing perianal pathology
- •based on clinical (including PDAI) and radiological (pelvic MRI and
- •endoanal ultrasound) criteria / Presence of 3 or less fistulous tracts / No
- •inflamatory activity in the rectum or proctitis (confirmed by
- •colonoscopy) / Written informed consent
- •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 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Superficial fistulas whose treatment of choice is fistulotomy / Presence
- •of more than 3 fistulous tracts / Rectourethral and rectovaginal fistulas
- •/ Endoanal abscesses larger than 2 cm detected by physical examination
- •or imaging (pelvic MRI endoanal ultrasound) / Current anorectal tumors
- •/ Clinically significant anal fissures or stenosis which prevent the
- •rectoscopy or similar procedures / Impossibility of performing MRI for
- •any reason (prosthesis, contrast allergy, claustrophobia ...) /
- •Impossibility of performing endoanal ultrasound for any reason /
- •Clinically inactive fistulizing disease (including PDAI) / Pregnant
- •women or women in the first 6 months post-partum / Chemotherapy
- •performed in the 6 months prior to study inclusion/ Bleeding diathesis or
- •concurrent anticoagulant therapy / Prior
- •radiation with evidence of radiation injury in the treatment area /
- •Participation in any clinical trial during the 3 months prior to the
- •screening visit / Other serious conditions or bio-psycho-social factors
- •that may predict lack of compliance with study procedures / Major
- •surgery or serious trauma of the subject in the previous semester /
- •Congenital or acquired immunodeficiencies / Presence of surgical
- •threads, unless they can be removed before starting treatment / Severe
- •proctitis (striking friability, spontaneous bleeding, multiple erosions,
- •deep ulcers), judging by the sigmoidoscopy / Malignancy in remission
- •for less than a years before study inclusion, with the exception of basal
- •cell carcinoma (BCC).
研究者
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