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Collagenase Clostridium Histolyticum for Refractory Iatrogenic Esophageal Strictures

NCT03898661 · Status: TERMINATED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2023-09-13

No results posted yet for this study

Summary

In this open-label pilot study we want to investigate whether intralaesional injection with collagenase clostridium histolyticum (XiapexR) into the esophageal stricture followed by dilation 24 hours later improves the outcome of patients with refractory esophageal anastomotic strictures as compared to dilation alone (standard of care).

Conditions

  • Stricture
  • Esophageal Stricture
  • Anastomotic
  • Collagenosis

Interventions

DRUG

Collagenase histiolyticum

local injection of collagenase histiolyticum into the esophageal stricture, 1 day before balloon dilation

Sponsors & Collaborators

  • University Hospital, Ghent

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-29
Primary Completion
2020-06-30
Completion
2021-01-01

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03898661 on ClinicalTrials.gov