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

NCT ID: NCT02477930

Last Updated: 2025-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

65 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-01

Study Completion Date

2023-09-21

Brief Summary

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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.

Detailed Description

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Conditions

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Intestinal Anastomotic Leak Intestinal Perforations

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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No interventions are done

No intervention is done. This is a registry study.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Baylor Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Steven Leeds, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor Health Care System

Locations

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Baylor University Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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014-263

Identifier Type: -

Identifier Source: org_study_id

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