Esophagus Injury Clinical Trial
— VeloxOfficial 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
NCT number | NCT05476263 |
Other study ID # | 2022-03 |
Secondary ID | |
Status | Not yet recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 2024 |
Est. completion date | September 2027 |
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.
Status | Not yet recruiting |
Enrollment | 110 |
Est. completion date | September 2027 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - = 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
Germany | Central Interdisciplinary Endoscopy, II. Medical Clinic Mannheim Medical University | Mannheim | |
Germany | Clinic for general, visceral and transplant surgery at the University of Munich | Munich |
Lead Sponsor | Collaborator |
---|---|
Lohmann & Rauscher | CRI-The Clinical Research Institute GmbH |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
3 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04162249 -
High Radiofrequency Power for Faster and Safer Pulmonary Veins Isolation - a Pilot Observational Study.
|
||
Completed |
NCT04196582 -
LMA® Gastro Airway Versus Gastro-Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography
|
N/A | |
Completed |
NCT05360810 -
Wei Nasal Jet Tube vs Gastro Laryngeal Tube in Endoscopic Retrograde Cholangiopancreatography
|
N/A | |
Completed |
NCT05709756 -
Prevalence and Predictors of Esophageal Thermal Lesions in High-power-Short-duration Ablation of Atrial Fibrillation
|
||
Recruiting |
NCT05330910 -
Crural Repair During Laparoscopic Sleeve Gastrectomy in Patients With a Lax Gastroesophageal Junction
|
N/A |