NCT04571541

Brief Summary

The study aim at comparing outcomes from the implementation of various endoscopic closure techniques including stenting and suturing on the healing and resolution of esophageal wall defects.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
6.2 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 1, 2020

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

11 years

First QC Date

September 26, 2020

Last Update Submit

February 16, 2026

Conditions

Esophageal FistulaEsophageal Perforation

Outcome Measures

Primary Outcomes (1)

  • Resolution of esophageal wall defect

    Resolution of esophageal wall defect

    7/1/2014 to 7/1/2022

Interventions

StentingDEVICE

Effect of endoscopic stenting on healing of esophageal wall defects

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients who present who our medical center with existing esophageal wall defect seeking endoscopic treatment and management

You may qualify if:

  • Any patient with spontaneous or iatrogenic esophageal wall defect

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Esophageal FistulaEsophageal Perforation

Interventions

Stents

Condition Hierarchy (Ancestors)

Digestive System FistulaDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsWounds and Injuries

Intervention Hierarchy (Ancestors)

Prostheses and ImplantsEquipment and Supplies

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine

Study Record Dates

First Submitted

September 26, 2020

First Posted

October 1, 2020

Study Start

July 1, 2014

Primary Completion

July 1, 2025

Study Completion

July 1, 2025

Last Updated

February 18, 2026

Record last verified: 2026-02

Locations

US(1)