Intestinal Anastomotic LeakNCT02477930
Endosponge Vacuum Therapy (E-VAC) Registry of Intestinal Anastomotic Leaks and Perforations
An observational study of Intestinal Anastomotic Leak and Intestinal Perforations, run by Baylor Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Anastomotic Leak, Intestinal Perforations
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 21 Sep 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All patients undergoing E-Vac Therapy
- Age > 17 years
Who cannot join
- 17 years of age or younger
- Undergone an E-Vac placement > 14 days before consenting
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
Official title: Prospective Registry The Treatment Of Upper And Lower Intestinal Anastomotic Leaks And Perforations
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.
- Being tested
- No interventions are done
- Medical subject headings
- Intestinal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventions are doneOther
No intervention is done. This is a registry study.
What is being measured
The primary outcome is the main question the study is designed to answer.
In-Hospital survival-rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study start1 Nov 2014
- Primary completion21 Sep 2023
- Study completion21 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal Anastomotic LeakStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven Leeds, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477930
- Sponsor's protocol ID
- 014-263
- Status last verified
- May 2025
- First submitted
- 19 Jun 2015
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry The Treatment Of Upper And Lower Intestinal Anastomotic Leaks And Perforations
- ClinicalTrials.gov ID
- NCT02477930
- Acronym / sponsor ID
- 014-263
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 21 Sep 2023 (actual)
- Study completion
- 21 Sep 2023 (actual)
- First posted
- 23 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- All patients undergoing E-Vac Therapy
- Age > 17 years
Key exclusion criteria (2 listed)
- 17 years of age or younger
- Undergone an E-Vac placement > 14 days before consenting
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventions are doneNo intervention is done. This is a registry study. | Other | – |
Primary outcome
In-Hospital survival-rate
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Leeds, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intestinal Anastomotic Leak and Intestinal Perforations, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-Hospital survival-rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.