Perforation EsophagusVACStentNCT03962179
Feasibility and Efficacy of a Combination of a SEMS and Vacuum Wound Treatment (VACStent)
A study testing VACStent in people with Perforation Esophagus and Esophageal Cancer, run by University Hospital of Cologne at 1 site in Germany.
Trial summary
Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication. Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perforation Esophagus, Esophageal Cancer, Esophageal Achalasia
- What is being tested?
- VACStent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteGermany
- Study dates
- 22 Sep 2019to 30 Nov 2021
- Phase
- Interventional
- 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
Who may be able to join
- Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination
- Accessibility of the leak with the delivery system of the VAC stent
Who cannot join
- Simultaneous participation in other interventional exams
- Endoscopic inaccessibility of the affected section
- Full anticoagulation with international normalized ratio (INR) > 1.5 and / or partial thromboplastin time (PTT) > 50 sec, or platelets <20.000 / μl (after therapeutic correction an inclusion is possible)
- Unstable patients with severe septic disease, who have a clinical history
- Assessment an immediate operation for safe focus switch-off requires
- Ileus image with constant vomiting (after nasogastric tube and gastric emptying an inclusion possible)
- Persons who are in a dependency / employment relationship with the sponsor or examiner stand
- Accommodation in an institution for judicial or regulatory purposes arrangement
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
About this study
Official title: VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
Read the detailed description
The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract
- Being tested
- VACStent
- Keywords
- Perforation Esophagus, Esophageal Anastomotic Leak,
- Medical subject headings
- Esophageal Perforation, Esophageal Neoplasms, Esophageal Achalasia, Esophageal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VACStentDevice
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
| Study group | Role | What they receive |
|---|---|---|
| VACStent Group | Experimental | Patient s who received a VACStent Receives: Device: VACStent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Technique - % of patients with successful implantation of VACStent
% of patients with successful implantation of VACStent
Measured: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Secondary outcomes (6)
Healing of leak - % of patients with successful implantation of VACStent
% of patients with a sealed leak after successful treatment with VACStent
Measured: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Treatment of sepsis
% of patients with successful treatment of sepsis leak after successful implantation of VACStent
Measured: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Migration rate
% of patients with migration of VACStent after successful implantation of VACStent
Measured: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Bleeding
% of patients with bleeding after successful implantation of VACStent
Measured: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Arrosion of tissue structures
% of patients with % of patients with bleeding after successful implantation of VACStent after successful treatment with VACStent
Measured: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Sealing of leak - % of patients with successful implantation of VACStent
% of patients with a sealed leak after successful treatment with VACStent
Measured: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2019
- Study start22 Sep 2019
- Primary completion30 Nov 2020
- Study completion30 Nov 2021 (estimated)
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 EsophagusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital of Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Hun Chon, University Hospital of Cologne
- Investigators
- Seung-Hun Chon, M.D., Principal investigator, University Hospital of Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03962179
- Sponsor's protocol ID
- 19-1053_1
- Acronym
- VACStent
- Status last verified
- Jul 2021
- First submitted
- 21 May 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chon SH, Bartella I, Burger M, Rieck I, Goeser T, Schroder W, Bruns CJ. VACStent: a new option for endoscopic vacuum therapy in patients with esophageal anastomotic leaks after upper gastrointestinal surgery. Endoscopy. 2020 May;52(5):E166-E167. doi: 10.1055/a-1047-0244. Epub 2019 Dec 2. No abstract available.
PubMed 31791095Chon SH, Scherdel J, Rieck I, Lorenz F, Dratsch T, Kleinert R, Gebauer F, Fuchs HF, Goeser T, Bruns CJ. A new hybrid stent using endoscopic vacuum therapy in treating esophageal leaks: a prospective single-center experience of its safety and feasibility with mid-term follow-up. Dis Esophagus. 2022 Apr 19;35(4):doab067. doi: 10.1093/dote/doab067.
PubMed 34561712
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VAC Stent: A Prospective Feasibility Study for the Treatment of Gastrointestinal Leakage Through a Combination of Covered Nitinol Stent and Negative Pressure Wound Treatment
- ClinicalTrials.gov ID
- NCT03962179
- Acronym / sponsor ID
- VACStent / 19-1053_1
- Keywords
- Perforation Esophagus, Esophageal Anastomotic Leak,
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University Hospital of CologneUniversity, hospital or other
- Study start
- 22 Sep 2019 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 30 Nov 2021 (estimated)
- First posted
- 23 May 2019 (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.
Open, prospective, one-arm feasibility and efficacy study of a European conformity (CE) certified Combination product of two CE certified medical devices in the intended indication.
Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
Detailed description
The investigators analyzed the outcome of using a hybrid medical device (self-expanding metal stents (SEMS) with negative pressure wound therapy) in the treatment of leaks of the upper gastrointestinal tract
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VACStent Group | Experimental | Device: VACStentPatient s who received a VACStent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with spontaneous, iatrogenic or postoperative leakage in the esophagus, evidence of leakage through an endoscopic examination
- Accessibility of the leak with the delivery system of the VAC stent
Key exclusion criteria (8 listed)
- Simultaneous participation in other interventional exams
- Endoscopic inaccessibility of the affected section
- Full anticoagulation with international normalized ratio (INR) > 1.5 and / or partial thromboplastin time (PTT) > 50 sec, or platelets <20.000 / μl (after therapeutic correction an inclusion is possible)
- Unstable patients with severe septic disease, who have a clinical history
- Assessment an immediate operation for safe focus switch-off requires
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 |
|---|---|---|
| VACStentEvaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract | Device | VACStent Group |
Primary outcome
Technique - % of patients with successful implantation of VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
% of patients with successful implantation of VACStent
6 secondary outcomes
Healing of leak - % of patients with successful implantation of VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Treatment of sepsis
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Migration rate
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Bleeding
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Arrosion of tissue structures
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Sealing of leak - % of patients with successful implantation of VACStent
Time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 31791095Chon SH, Bartella I, Burger M, Rieck I, Goeser T, Schroder W, Bruns CJ. VACStent: a new option for endoscopic vacuum therapy in patients with esophageal anastomotic leaks after upper gastrointestinal surgery. Endoscopy. 2020 May;52(5):E166-E167. doi: 10.1055/a-1047-0244. Epub 2019 Dec 2. No abstract available.
- Derived from this study: PubMed 34561712Chon SH, Scherdel J, Rieck I, Lorenz F, Dratsch T, Kleinert R, Gebauer F, Fuchs HF, Goeser T, Bruns CJ. A new hybrid stent using endoscopic vacuum therapy in treating esophageal leaks: a prospective single-center experience of its safety and feasibility with mid-term follow-up. Dis Esophagus. 2022 Apr 19;35(4):doab067. doi: 10.1093/dote/doab067.
- Individual participant dataSharing planned: No
Related trials for Perforation Esophagus
Enrolling by invitationObservational study
Exploring the Landscape of Injury and Repair in the Human Oesophagus
Perforations to the Oesophagus
RecruitingObservational study
Endoscopic Vacuum Therapy for Transmural Defects in the Upper Gastrointestinal Tract
Endoscopic Vacuum Therapy, Anastomotic Leak
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.
Seung-Hun Chon, M.D. principal investigator
University Hospital of Cologne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VACStent in people with Perforation Esophagus and Esophageal Cancer, run by University Hospital of Cologne at 1 site 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 8 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: status not confirmed, as of the sponsor's last update on 5 Aug 2021. 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 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?
Results are not available in the source record.
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?
Technique - % of patients with successful implantation of VACStent (time frame: From date of first implantation of VACStent until the leak is sealed or the treatment is canceled from any serious medical cause, whichever came first, up to 12 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 NCT03962179, 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 5 Aug 2021.