Perforation of the OesophagusNCT04884334
VAC-Stent Registry
An observational study of Perforation of the Oesophagus and Perforation of the Colon, run by Markus M. Heiss at 14 sites in Germany.
Trial summary
This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon. Furthermore, the safety and efficacy of the VAC-Stent® shall be proven. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforation of the Oesophagus, Perforation of the Colon
- What is being tested?
- VAC-Stent®
- Type of treatment
- Medical device
- How many people
- 110 participants
- Where
- 14 sitesGermany
- Study dates
- 1 Jul 2020to 1 Apr 2026
- How long will I take part?
- 4 Weeks
- 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: Patients with spontaneous, iatrogenic or postoperative leakages in the oesophagus or colon
Who may be able to join
- written informed consent
- treatment with the VAC-Stent®
Who cannot join
- accommodation in an institution under court or administrative order
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Germany14 sites
Charité
Berlin
Sana Klinikum Lichtenberg
Berlin
St. Josef-Hospital
Bochum
Johanniter Krankenhaus Bonn
Bonn
Ameos Klinikum Am Bürgerpark
Bremerhaven
Allgemeines Krankenhaus Celle
Celle
Visceral, Tumour, Vascular and Transplant Surgery, Cologne Merheim Hospital
Cologne, 51109
Städtisches Klinikum Dresden
Dresden
Uniklinik Düsseldorf
Düsseldorf
KRH Klinikum Siloah
Hanover
Nils Stensen Kliniken, Marienhospital Osnabrück
Osnabrück
Caritas Klinikum Saarbrücken - St. Theresia
Saarbrücken
Uniklinik Tübingen
Tübingen
Asklepios Paulinen Klinik Wiesbaden
Wiesbaden
About this study
Official title: Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon. Furthermore, the safety and efficacy of the VAC-Stent® shall be proven.
Read the detailed description
For this registry, quality assurance data will be prospectively collected from all patients who receive the VAC-Stent®. The VAC-Stent® combines a vacuum sponge, which lies intraluminal and conditions the wound, with a covered stent, which seals the sponge from the lumen and thus ensures passage. Due to its design, the new medical device VAC-Stent® offers a solution for the most important problems of the covered stent, the stent migration and the lack of drainage function, as well as for those of the endoluminal vacuum sponge, the blockage of the gastrointestinal lumen and the difficult application. The VAC-Stent® is the technical advancement for all indications of the covered stent and for the indication of the endoluminal vacuum sponge, so that a very good effectiveness with reduced complications can be expected for these clinical situations.
The VAC-Stent® therefore offers the prospect of an innovative further development in the endoscopic treatment of leaks in the gastrointestinal tract, without any new and unknown risks being associated with it.
The primary aim of this registry is to collect data on the quality assurance and application of the VAC-Stent® and thus to evaluate the suitability of the VAC-Stent® for sealing leaks in the oesophagus or colon. In addition, the safety and efficacy of the VAC-Stent® will be demonstrated.
- Being tested
- VAC-Stent®
- Keywords
- Perforation Oesophagus, Oesophageal Anastomotic Leak, endoscopic vacuum therapy, Perforation Colon
- Medical subject headings
- Esophageal Perforation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VAC-Stent®Device
treatment with the VAC-Stent®
| Study group | Role | What they receive |
|---|---|---|
| VAC-Stent® treatment | spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon Receives: Device: VAC-Stent® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful treatment of the leakage with the VAC-Stent®
Measured: up to 6 months
Secondary outcomes (2)
Rate of morphological healing of the insufficiency
Measured: approximately 4 weeks after end of treatment
Number of Participants with complications
Measured: approximately 4 weeks after end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2021
- Study start1 Jul 2020
- Primary completion1 Apr 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Perforation of the OesophagusStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- Markus M. Heiss
- Sponsor type
- University, hospital or other
- Collaborators
- VAC Stent GmbH, Möller Medical GmbH, MicroTech Europe GmbH, University of Witten/Herdecke
- Responsible party
- Sponsor-investigator, Markus M. Heiss, University of Witten/Herdecke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04884334
- Sponsor's protocol ID
- VAC-Stent Registry
- Status last verified
- Apr 2026
- First submitted
- 4 May 2021
- Last updated
- 15 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Heiss MM, Lange J, Knievel J, Yohannes A, Hugle U, Dormann AJ, Eisenberger CF. Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study. Langenbecks Arch Surg. 2024 Jul 31;409(1):234. doi: 10.1007/s00423-024-03426-5.
PubMed 39083099Lange J, Knievel J, Wichmann D, Kahler G, Wiedbrauck F, Hellmich T, Kandler M, Bernhardt J, Scholz D, Beyna T, Hausmann J, Wedi E, Ellrichmann M, Hugle U, Dormann AJ, Eisenberger CF, Heiss MM. Clinical implantation of 92 VACStents in the upper gastrointestinal tract of 50 patients-applicability and safety analysis of an innovative endoscopic concept. Front Surg. 2023 May 5;10:1182094. doi: 10.3389/fsurg.2023.1182094. eCollection 2023.
PubMed 37215348
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection on the Treatment of Gastrointestinal Leakage by the Use of Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
- ClinicalTrials.gov ID
- NCT04884334
- Acronym / sponsor ID
- VAC-Stent Registry
- Keywords
- Perforation Oesophagus, Oesophageal Anastomotic Leak, endoscopic vacuum therapy, Perforation Colon
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Markus M. HeissUniversity, hospital or other
- Collaborators
- VAC Stent GmbH, Möller Medical GmbH, MicroTech Europe GmbH, University of Witten/Herdecke
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Apr 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 13 May 2021 (actual)
- 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.
This registry is intended to collect data on quality assurance and use of the VAC-Stent® and thus verify the suitability of the VAC-Stent® for sealing leakages in the oesophagus or colon. Furthermore, the safety and efficacy of the VAC-Stent® shall be proven.
Detailed description
For this registry, quality assurance data will be prospectively collected from all patients who receive the VAC-Stent®. The VAC-Stent® combines a vacuum sponge, which lies intraluminal and conditions the wound, with a covered stent, which seals the sponge from the lumen and thus ensures passage. Due to its design, the new medical device VAC-Stent® offers a solution for the most important problems of the covered stent, the stent migration and the lack of drainage function, as well as for those of the endoluminal vacuum sponge, the blockage of the gastrointestinal lumen and the difficult application. The VAC-Stent® is the technical advancement for all indications of the covered stent and for the indication of the endoluminal vacuum sponge, so that a very good effectiveness with reduced complications can be expected for these clinical situations.
The VAC-Stent® therefore offers the prospect of an innovative further development in the endoscopic treatment of leaks in the gastrointestinal tract, without any new and unknown risks being associated with it.
The primary aim of this registry is to collect data on the quality assurance and application of the VAC-Stent® and thus to evaluate the suitability of the VAC-Stent® for sealing leaks in the oesophagus or colon. In addition, the safety and efficacy of the VAC-Stent® will be demonstrated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 4 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VAC-Stent® treatment | – | Device: VAC-Stent®spontaneous, iatrogenic or postoperative leakage of the oesophagus or colon |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spontaneous, iatrogenic or postoperative leakages in the oesophagus or colon
Key inclusion criteria (2 listed)
- written informed consent
- treatment with the VAC-Stent®
Key exclusion criteria (1 listed)
- accommodation in an institution under court or administrative order
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 |
|---|---|---|
| VAC-Stent®treatment with the VAC-Stent® | Device | VAC-Stent® treatment |
Primary outcome
Successful treatment of the leakage with the VAC-Stent®
Time frame: up to 6 months
2 secondary outcomes
Rate of morphological healing of the insufficiency
Time frame: approximately 4 weeks after end of treatment
Number of Participants with complications
Time frame: approximately 4 weeks after end of treatment
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 15 Apr 2026.
- Derived from this study: PubMed 39083099Heiss MM, Lange J, Knievel J, Yohannes A, Hugle U, Dormann AJ, Eisenberger CF. Treatment of anastomotic leak in colorectal surgery by endoluminal vacuum therapy with the VACStent avoiding a stoma - a pilot study. Langenbecks Arch Surg. 2024 Jul 31;409(1):234. doi: 10.1007/s00423-024-03426-5.
- Derived from this study: PubMed 37215348Lange J, Knievel J, Wichmann D, Kahler G, Wiedbrauck F, Hellmich T, Kandler M, Bernhardt J, Scholz D, Beyna T, Hausmann J, Wedi E, Ellrichmann M, Hugle U, Dormann AJ, Eisenberger CF, Heiss MM. Clinical implantation of 92 VACStents in the upper gastrointestinal tract of 50 patients-applicability and safety analysis of an innovative endoscopic concept. Front Surg. 2023 May 5;10:1182094. doi: 10.3389/fsurg.2023.1182094. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perforation of the Oesophagus and Perforation of the Colon, run by Markus M. Heiss at 14 sites in Germany.
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 1 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 15 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Germany. 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?
Successful treatment of the leakage with the VAC-Stent® (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04884334, which also lists 2 linked publications.
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 15 Apr 2026.