Glue Sealing for Patients With Low-Output ECFs
Launched by JINLING HOSPITAL, CHINA · Aug 22, 2012
Trial Information
Current as of April 30, 2025
Unknown status
Keywords
ClinConnect Summary
* This is a prospective, randomized, single-centered study clinical, safety and economic outcome of ECFs patients.
* Subjects are randomized to one of 2 groups:
* Group 1: Autologous PRFG-treatment (PRFG + SOC)
* Group 2: Commercial FG-treatment (Bioseal® + SOC)
* Study will include three phases:
* Phase 1: Screening, consent and enrollment
* Phase 2: Patients will receive either PRFG, or Bioseal only for 14 days
* Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated ...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Patients with a single tubular ECF
- • Low output volume (\<200 ml/24h)
- • Tract length \>2cm
- • Tract diameter \< 1cm
- Exclusion Criteria:
- • Cancer-infiltrated fistula
- • Abscess
- • Foreign bodies
- • Distal bowel obstruction
- • Inflammatory bowel disease
About Jinling Hospital, China
Jinling Hospital, located in Nanjing, China, is a prominent healthcare institution renowned for its commitment to advanced medical research and comprehensive patient care. As a key clinical trial sponsor, Jinling Hospital leverages its robust clinical expertise and state-of-the-art facilities to facilitate innovative research initiatives that aim to improve therapeutic outcomes across various medical fields. With a dedicated team of experienced researchers and healthcare professionals, the hospital fosters collaboration and adheres to rigorous ethical standards, ensuring the integrity and quality of its clinical trials while contributing to the global advancement of medical science.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Nanjing, Jiangsu, China
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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