Endosponge Vacuum Therapy (E-VAC) Registry of Intestinal Anastomotic Leaks and Perforations

Intestinal Anastomotic Leak Clinical Trial

Official title:

Prospective Registry The Treatment Of Upper And Lower Intestinal Anastomotic Leaks And Perforations

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02477930
• Other study ID #: 014-263
• Status: Active, not recruiting
• Start date: November 1, 2014
• Est. completion date: July 2025

Study information

• Verified date: June 2020
• Source: Baylor Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this registry is to collect data on the clinical use of endoluminal vacuum (E-Vac) therapy to treat both upper and lower intestinal leaks and perforations.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients undergoing E-Vac Therapy

• Age > 17 years

Exclusion Criteria:

• 17 years of age or younger

• Undergone an E-Vac placement > 14 days before consenting

Related Conditions & MeSH terms

• Anastomotic Leak
• Intestinal Anastomotic Leak
• Intestinal Perforation
• Intestinal Perforations

Intervention

Other:
• No interventions are done
No intervention is done. This is a registry study.

Locations

Country	Name	City	State
United States	Baylor University Medical Center	Dallas	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-Hospital survival-rate		6 months