NCT03898661

Brief 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).

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 2, 2019

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2021

Completed
Last Updated

September 13, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

March 29, 2019

Last Update Submit

September 7, 2023

Conditions

StrictureEsophageal StrictureAnastomoticCollagenosis

Keywords

Xiapexesophageal stricturestricturecollagenaserefractoryanastomotic

Outcome Measures

Primary Outcomes (1)

  • Number of repeat dilations that are required over a timespan of 6 months.

    6 months

Secondary Outcomes (3)

  • time to first repeat dilation

    6 months

  • complication rate.

    6 months

  • Dysphagia score

    6 months

Study Arms (1)

local collagenase

EXPERIMENTAL

Patients receiving local injection of collagenase (0.9 mg XiapexR) into the esophageals stricture

Drug: Collagenase histiolyticum

Interventions

Collagenase histiolyticumDRUG

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

local collagenase

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • suffers from dysphagia caused by an iatrogenic esophageal stricture
  • the stricture is amenable for endoscopic dilation
  • the patient has undergone at least 1 previous endoscopic dilation for the same stricture
  • signed the ICF

You may not qualify if:

  • the patient is not fluent in Dutch

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hindryckx

Zwijnaarde, 9052, Belgium

Location

MeSH Terms

Conditions

Constriction, PathologicEsophageal Stenosis

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2019

First Posted

April 2, 2019

Study Start

March 29, 2019

Primary Completion

June 30, 2020

Study Completion

January 1, 2021

Last Updated

September 13, 2023

Record last verified: 2023-09

Locations

BE(1)