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| Name | Class |
|---|---|
| Ludwig-Maximilians - University of Munich | OTHER |
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randomized, controlled single center, single investigator study mainly in colorectal screening population in daily practice with and without artificial intelliegence (AI) named DiscoveryTM from Pentax medical. Patient randomly are allocated to one of four groups: Pentax i10 colonoscopes without any additional device, Pentax i 10 with DiscoveryTM (AI), Pentax i 10 with EndocuffTM and Pentax i10 with EndocuffTM and DiscoveryTM (AI).
The different groups are compared in terms of the different parameters: e.g. time of endoscopy, polyps (PDR) and adenoma detected (ADR).
From August 2021 through August 2022 all patients undergoing a colonoscopy in a gastroenterologist's private practice are assigned using randomization tables to one or the other above mentioned groups. Time of the endoscopy (ascent, descent and intervention time), polyps detected and their histology are written down real time with a tablet computer anonymized with the patient number. Furthermore dosage of sedatives and over all satisfaction is traced.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pentax i 10 | No Intervention | Patient gets normal colonoscopy without Endocuff or activation of artifical intelligence | |
| Pentax i 10 with artificial intelligence Discovery TM | Active Comparator | Normal Pentax i 10 colonoscope with on the special monitor acitvated artificial intelligence |
|
| Pentax i 10 with Endocuff TM | Active Comparator | Endocuff cap is mounted on the tip of the endoscope a cheap assistance device proven in former studies to increase adenoma detection rate. |
|
| Pentax i 10 with Endocuff TM and artificial intelligence Discovery TM | Active Comparator | Endocuff cap is mounted on the tip of the endoscope and artificial intelligence is activated on the monitor. hypothesis is that probably artificial intelligence and Endocuff combined potentiate their effect. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Discovery TM of Pentax medical on/off in colonoscopy | Device | on the monitor artificial integlligence Discovery can be switched on or off. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopy time | measurement of ascent, descent and intervention time during colonoscopy | within 45 minutes of examination |
| Measure | Description | Time Frame |
|---|---|---|
| polyp and adenoma detetction rate PDR and ADR | counts of polypes and their location in the colon and their histology | within 45 minutes of examination |
| Measure | Description | Time Frame |
|---|---|---|
| Medication dosage | Dosage of Propofol and Buscopan | withn 45 minutes of examination |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Martin Geyer | Wettingen | Canton of Aargau | 5430 | Switzerland |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D000236 | Adenoma |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D003113 | Colonoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
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|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |