Esophagus InjuryVeloxNCT05476263
Suprasorb® CNPendo Used for Negative Pressure Therapy in the Oesophagus and Rectum to Support Defect and Wound Healing
An observational study of Esophagus Injury and Rectal Lesion, run by Lohmann & Rauscher at 7 sites in Germany.
Trial summary
A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Esophagus Injury, Rectal Lesion
- How many people
- 110 participants
- Where
- 7 sitesGermany
- Study dates
- 3 Jun 2024to Sep 2027
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Adult female and male patients with acute defects, injuries and wounds in the oesophagus or rectum and an indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines.
Who may be able to join
- ≥ 18 years of age
- Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Index defect)
- Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines
- Signed informed consent for usage of data
Who cannot join
- Pre-existing coagulation disorders with increased risk of bleeding
- Defects involving the bronchial system (bronchus/trachea/pulmo)
- Any foreseeable deviation from IFU of Suprasorb® CNP endo
- Known intolerance or allergy to one or more components of Suprasorb® CNPendo
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
Germany7 sites, 7 recruiting
- Recruiting
Uniklinik Berlin Charite
Berlin
Konstantinos Kouladouros, MD
- Recruiting
Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University
Mannheim
Sebastian Belle, MD, Prof
- Recruiting
Clinic for general, visceral and transplant surgery at the University of Munich
Munich
Maria Burian, MD
- Not yet recruiting
Uniklinik MRI
Munich
Jeannine Bachmann, MD
- Recruiting
Universitätsklinikum Münster (UKM) Klinik für Allgemein-, Viszeral- und Transplantationschirurgie
Münster, 48149
Jennifer Merten, MD
- Recruiting
Klinikum Rheine, Mathias-Spital, Chirurgische Klinik I: Allgemein- und Viszeralchirurgie
Rheine, 48431
Mike Laukötter, Prof., MD
- Recruiting
Universitätsklinikum Tübingen, Innere Medizin I - Gastroenterologie, Gastrointestinale Onkologie, Hepatologie, Infektiologie und Geriatrie
Tübingen, 72076
Ulrike Schlempf, MD
About this study
Official title: Non-interventional, Observational, Prospective, Multicentre Study in a Routine Clinical Care Setting Using a Marketed Medical Device in Line With the Corresponding IFU in the Intended Patient Population
A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population.
Patients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. They will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations.
The study protocol does not define specific study procedures for patients enrolled. Therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.
- Conditions
- Esophagus Injury, Rectal Lesion
What is being measured
The primary outcome is the main question the study is designed to answer.
Time period in days from index use of Suprasorb® CNPendo to release for oral food intake (in upper GI tract use) or release for stoma relocation (in lower GI tract use).
Time period in days from index use of Suprasorb® CNPendo to release for oral food intake (in upper GI tract use) or release for stoma relocation (in lower GI tract use).
In case of lower GI tract use and no stoma present, time period to release for oral food intake is the relevant endpoint.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2022
- Study start3 Jun 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Esophagus InjuryStudies 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 (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Lohmann & Rauscher
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRI-The Clinical Research Institute GmbH
- Responsible party
- Sponsor
- Investigators
- Mike Laukötter, Prof., MD, Principal investigator, Klinikum Rheine, Mathias-Spital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05476263
- Sponsor's protocol ID
- 2022-03
- Acronym
- Velox
- Status last verified
- Sep 2024
- First submitted
- 25 Jul 2022
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional, Observational, Prospective, Multicentre Study in a Routine Clinical Care Setting Using a Marketed Medical Device in Line With the Corresponding IFU in the Intended Patient Population
- ClinicalTrials.gov ID
- NCT05476263
- Acronym / sponsor ID
- Velox / 2022-03
- Conditions
- Esophagus Injury, Rectal Lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Lohmann & RauscherIndustry (pharma, biotech, devices)
- Collaborators
- CRI-The Clinical Research Institute GmbH
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 27 Jul 2022 (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.
A Post-Market Clinical Follow-up (PMCF) study designed as non-interventional, observational, prospective, multicentre study in a routine clinical care setting using a marketed medical device in line with the corresponding Instruction for Use (IFU) in the intended patient population.
Patients will be diagnosed and evaluated for eligibility in routine clinical care by expert centres in the indication of interest. They will be consecutively enrolled into the study provided that all inclusion and exclusion criteria are met and written consent is given to use their clinical routine data according to data privacy regulations.
The study protocol does not define specific study procedures for patients enrolled. Therapies and procedures during the course of this study will be performed according to the decision of the treating physician based on current applicable medical guidelines and on local policy in clinical routine care.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult female and male patients with acute defects, injuries and wounds in the oesophagus or rectum and an indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines.
Key inclusion criteria (4 listed)
- ≥ 18 years of age
- Acute transmural defects, injuries and wounds in oesophagus or rectum, including perforations (iatrogenic or spontaneous) and anastomotic insufficiencies (Index defect)
- Indication of treatment with Suprasorb® CNPendo system according to IFU and medical guidelines
- Signed informed consent for usage of data
Key exclusion criteria (4 listed)
- Pre-existing coagulation disorders with increased risk of bleeding
- Defects involving the bronchial system (bronchus/trachea/pulmo)
- Any foreseeable deviation from IFU of Suprasorb® CNP endo
- Known intolerance or allergy to one or more components of Suprasorb® CNPendo
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Time period in days from index use of Suprasorb® CNPendo to release for oral food intake (in upper GI tract use) or release for stoma relocation (in lower GI tract use).
Time frame: 3 months
Time period in days from index use of Suprasorb® CNPendo to release for oral food intake (in upper GI tract use) or release for stoma relocation (in lower GI tract use). In case of lower GI tract use and no stoma present, time period to release for oral food intake is the relevant endpoint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- 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.
Mike Laukötter, Prof., MD principal investigator
Klinikum Rheine, Mathias-Spital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Esophagus Injury and Rectal Lesion, run by Lohmann & Rauscher at 7 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daria Trofimenko, MD (+49 (0)2631- 99 6385, Daria.Trofimenko@de.LRmed.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time period in days from index use of Suprasorb® CNPendo to release for oral food intake (in upper GI tract use) or release for stoma relocation (in lower GI tract use). (time frame: 3 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 12 Sep 2025.