ocal injection of collagenase for difficult-to-treat scar strictures of the gastrointestinal tract.

Phase 1

• Conditions: refractory iatrogenic gastrointestinal strictures; MedDRA version: 21.0Level: LLTClassification code 10078825Term: Gastrointestinal anastomotic strictureSystem Organ Class: 100000004863; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2018-003637-14-BE
• Lead Sponsor: Ghent University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-09
• Last Update Posted: 24 January 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

The patient is 18-90 years old
The patient suffers from a gastrointestinal stricture
The stricture is amenable for endoscopic dilation
The patient has undergone at least 1 previous endoscopic dilation for the same stricture within the last 3 months
The patient has signed the ICF

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 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

The patient is not fluent in Dutch

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified