NCT05606822 Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract
| NCT ID | NCT05606822 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Condition | Endoscopic Vacuum Therapy |
| Study Type | OBSERVATIONAL |
| Enrollment | 200 participants |
| Start Date | 2021-10-01 |
| Primary Completion | 2030-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 200 participants in total. It began in 2021-10-01 with a primary completion date of 2030-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this observational study is to learn about the best indications and techniques regarding endoscopic vacuum therapy (EVT) in patients with a transmural defect in the upper gastrointestinal (GI) tract (e.g. anastomotic leakage, Boerhaave syndrome, iatrogenic perforation, other). The main questions it aims to answer are: * What is the success rate of EVT for transmural defects in the upper GI tract? * What are the best indications for EVT in the upper GI tract? (e.g. etiology, patient characteristics, defect characteristics) * What are the best techniques for EVT in the upper GI tract? (e.g. EsoSponge, VACStent, vacuum pressure, intraluminal/intracavitary) Participants will be asked for informed consent to retrospectively and prospectively collect data on EVT.
Eligibility Criteria
Inclusion Criteria: * Treated with EVT for anastomotic leakage after esophago-gastric surgery * Signed informed consent form * 18 years or older Exclusion Criteria: * No signed informed consent
Contact & Investigator
Roos Pouw, MD, PhD
PRINCIPAL INVESTIGATOR
Amsterdam University Medical Center, location VU
Frequently Asked Questions
Who can join the NCT05606822 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Endoscopic Vacuum Therapy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05606822 currently recruiting?
Yes, NCT05606822 is actively recruiting participants. Contact the research team at r.e.pouw@amsterdamumc.nl for enrollment information.
Where is the NCT05606822 trial being conducted?
This trial is being conducted at Amsterdam, Netherlands.
Who is sponsoring the NCT05606822 clinical trial?
NCT05606822 is sponsored by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). The principal investigator is Roos Pouw, MD, PhD at Amsterdam University Medical Center, location VU. The trial plans to enroll 200 participants.