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TerminatedNCT00252369Updated Apr 24, 2009

Treatment of Perianal Crohn's Disease, Combining Medical and Surgical Treatment.

An interventional study of Infliximab and Instillation of fibrin glue in Crohn's Disease, sponsored by Sheba Medical Center. Terminated at 4 sites in Israel. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2009-04-24.

Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment

Why this study was terminated
Low accrual rate
Phase
Not applicable
Study type
Interventional
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
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Study summary

This study is aimed to assess the hypothesis that instillation of fibrin glue with the induction of local conditions using Infliximab, may be useful in the treatment of perianal Crohn's disease.

Read the detailed description

Patients with perianal fistulae of Crohn's disease will be prospectively enrolled and receive 3 doses of Infliximab. If reduction of fistula associated discharge of at least 50% will be recorded, commercially available fibrin glue will be instilled into the fistula tract using standard surgical techniques. The patients will be followed for 6 months for fistula healing and complications.

02

Conditions studied

  • Crohn's Disease

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03

In context

Crohn Disease

1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.

Browse Crohn Disease studies →

Lead sponsor

Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Perianal fistula of Crohn's dis

Exclusion criteria

Exclusion Criteria:

  • More then 2 fistulae perianal sepsis known contraindication to infliximab or glue
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)

Interventions

  • DrugInfliximab
  • ProcedureInstillation of fibrin glue
06

What researchers measure

Primary outcomes

  1. Fistula healing

Secondary outcomes

  1. Quality of life

  2. Complications

07

Study locations

4 sites
  • Meir Medical Center
    Kfar Saba, Israel
  • Tel Aviv Medical Center
    Tel Aviv, Israel
  • Sheba Medical Center
    Tel Hashomer, Israel
  • Assaf Harofe Medical Center
    Zrifin, Israel
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00252369
Lead sponsor
Sheba Medical Center
First posted
Nov 11, 2005
Last update
Apr 24, 2009

Study contacts

Oded Zmora, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Apr 2009. You cannot join it, but the record below documents what was studied.

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