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CompletedNCT02477930Updated May 25, 2025

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

An observational study in Intestinal Anastomotic Leak and Intestinal Perforations, sponsored by Baylor Research Institute. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-05-25.

Sponsored by Baylor Research Institute · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
65
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Intestinal Anastomotic Leak
  • Intestinal Perforations

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03

In context

Intestinal Perforation

36 studies on the registry are indexed under Intestinal Perforation; 5 are open to participants now.

This study's enrollment of 65 is below the median of 203 across 20 observational studies indexed under Intestinal Perforation.

Browse Intestinal Perforation studies →

Lead sponsor

Baylor Research Institute is the lead sponsor of 223 studies on the registry; 48 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 9 (39%) have results posted.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patient's with upper and lower intestinal anastomotic leaks and perforations who are referred for E-Vac therapy or are the primary patients of Dr. Leeds and Dr. Burdick will be invited to participate in this registry.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • All patients undergoing E-Vac Therapy
  • Age > 17 years

Exclusion criteria

Exclusion Criteria:

  • 17 years of age or younger
  • Undergone an E-Vac placement > 14 days before consenting
05

Study design

Observational model
Other
Time perspective
Prospective
Enrollment
65 participants (actual)
Target follow-up
6 Months
Patient registry
Yes

Interventions

  • OtherNo interventions are done

    No intervention is done. This is a registry study.

06

What researchers measure

Primary outcomes

  1. In-Hospital survival-rate

    Time frame: 6 months

07

Study locations

1 site
  • Baylor University Medical Center
    Dallas, Texas 75246, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2014 to primary completion in Sep 2023, 106 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 19, 2015
First posted
Jun 23, 2015
StartActual
Nov 1, 2014
Primary completionActual
Sep 21, 2023
CompletionActual
Sep 21, 2023
Last update
May 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02477930
Lead sponsor
Baylor Research Institute
Responsible party
Sponsor
First posted
Jun 23, 2015
Start date
Nov 1, 2014
Primary completion
Sep 21, 2023
Completion
Sep 21, 2023
Last update
May 25, 2025

Study contacts

Steven Leeds, MD
principal investigator · Baylor Health Care System

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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