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| Name | Class |
|---|---|
| Ovesco Endoscopy AG | INDUSTRY |
| Tuebingen Scientific Medical GmbH | UNKNOWN |
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The goal of this clinical trial is to determine whether the use of the EndoTEM system during the endoscopic removal of polyps in the distal colon is feasible and safe.
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EndoTEM-System | Experimental | Utilization of the EndoTEM system in the performance of routine endoscopic en bloc resection using endoscopic submucosal dissection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EndoTEM resection platform and technique | Device | EndoTEM is a flexible transanally introduced port system that allows the insertion of a second instrument alongside the flexible endoscope. A curved rigid grasping instrument has been developed, with a 2 cm long tip that can be rotated and angled in all directions. |
| Measure | Description | Time Frame |
|---|---|---|
| Technical success of the endoscopic resection | Macroscopically complete resection. | From the endoscopic resection to the follow-up endoscopy after 6 months. |
| Measure | Description | Time Frame |
|---|---|---|
| R0 resection rate | Histological complete resection. | Assessed with a biopsy collected during the intervention. |
| En bloc resection rate | Endoscopic removal of the polyp in one intact piece, including any necessary surrounding tissue. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Arthur Schmidt, Prof. Dr. med. | Robert Bosch Krankenhaus GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsklinikum Freiburg, Klinik für Innere Medizin II | Not yet recruiting | Freiburg im Breisgau | 79106 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Mueller J, Miedtke V, Kuellmer A et al. A novel endoscopic technique and device for bimanual rectosigmoidal ESD. Endoscopy 2023; 55(S02): 264 - 264. doi:10.1055/s-0043-1765725 |
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|
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| Assessed during the intervention. |
| Duration of the procedure | From endoscope insertion until the end of procedure including supplementary and prophylactic interventions. |
| Resection time | From start of the resection until detachment of the specimen. |
| Resection speed | Resected area per minute (mm²/min). | Assessed during the intervention. |
| Periprocedural complications | Complications that occur during or immediately around the intervention (until 3-6 months post-intervention). |
| Requirement for surgical intervention | During the endoscopic submucosal dissection. |
| Rate of recurrence | Assessed during follow-up endoscopy 3-6 months post-intervention. |
| RKH Klinikum Ludwigsburg | Not yet recruiting | Ludwigsburg | 71640 | Germany |
|
| Robert Bosch Krankenhaus GmbH | Recruiting | Stuttgart | 70376 | Germany |
|
| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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